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A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART)

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ClinicalTrials.gov Identifier: NCT03878524
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Raymond Bergan, MD, OHSU Knight Cancer Institute

Brief Summary:
This Phase Ib study assesses feasibility and safety of a personalized medicine approach that utilizes a series of clinical study analytics to characterize the cancer based on DNA mutations, RNA and protein expression, physical and molecular architecture of the cancer tissue, and function of cells. This clinical study analytics will be considered by a tumor board to select therapeutic drug combinations tailored to each individual. The chosen drugs are intended to optimally inhibit and/or perturb biological pathways promoting the growth and/or survival of an individual participant's cancer. Serial biopsies and analytics will allow for the therapy to adapt as the patient's cancer adapts to biological perturbation. The study will include patients with advanced cancer of the breast (BCa), prostate (PCa), or pancreas (PanCa), or those with refractory acute myelogenous leukemia (AML).

Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Pancreatic Cancer Acute Myelogenous Leukemia Procedure: Biopsy Drug: ABIRATERONE Drug: ENZALUTAMIDE Drug: VENETOCLAX Drug: PALBOCICLIB Drug: All-trans Retinoic Acid Drug: BORTEZOMIB Drug: CABAZITAXEL Drug: OXALIPLATIN Drug: FLUOROURACIL Drug: FOLINIC ACID Drug: CARBOPLATIN Drug: PANOBINOSTAT Drug: VORINOSTAT Drug: PEMBROLIZUMAB Drug: BEVACIZUMAB Drug: IPILIMUMAB Drug: NIVOLUMAB Drug: EVEROLIMUS Drug: SIROLIMUS Drug: CELECOXIB Drug: OLAPARIB Drug: AFATINIB Drug: CABOZANTINIB Drug: SORAFENIB Drug: DASATINIB Drug: ERLOTINIB Drug: IDELALISIB Drug: IMATINIB Drug: LENVATINIB Drug: PERTUZUMAB Drug: PONATINIB Drug: RUXOLITINIB Drug: SUNITINIB Drug: TRAMETINIB Drug: VEMURAFENIB Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : February 27, 2021
Estimated Study Completion Date : February 27, 2021


Arm Intervention/treatment
Experimental: SMMART Therapy (Combination Drug A & B)
Following a tumor tissue/cell biopsy, participants will be assigned an individualized therapy Arm involving a combination two drugs (Drug A and Drug B) selected from a list of 35 drugs (ABIRATERONE, ENZALUTAMIDE, VENETOCLAX, PALBOCICLIB, All-trans Retinoic Acid , BORTEZOMIB, CABAZITAXEL, OXALIPLATIN, FLUOROURACIL, FOLINIC ACID, CARBOPLATIN, PANOBINOSTAT, VORINOSTAT, PEMBROLIZUMAB, BEVACIZUMAB, IPILIMUMAB, NIVOLUMAB, EVEROLIMUS, SIROLIMUS, CELECOXIB, OLAPARIB, AFATINIB, CABOZANTINIB, SORAFENIB, DASATINIB, ERLOTINIB, IDELALISIB, IMATINIB, LENVATINIB, PERTUZUMAB, PONATINIB, RUXOLITINIB, SUNITINIB, TRAMETINIB, VEMURAFENIB). Doses will be escalated on a monthly basis and is anticipated to occur as follows: first month -- 100% dose Drug A+25% dose Drug B; second month --100% dose Drug A + 50% dose Drug B; third month -- 100% dose Drug A + 100% dose Drug B. These drug agents may be administered in combination, either concurrently or serially depending on their respective pharmacology.
Procedure: Biopsy
Solid Tumor Biopsy for BCa, PCa or PanCa and Bone marrow biopsy for AML

Drug: ABIRATERONE
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: ZYTIGA®

Drug: ENZALUTAMIDE
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Xtandi®

Drug: VENETOCLAX
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Venclexta®

Drug: PALBOCICLIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: IBRANCE®

Drug: All-trans Retinoic Acid
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Names:
  • ATRA
  • tretinoin
  • Vesanoid®

Drug: BORTEZOMIB
Given IV (infusion) or Given SC; Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Velcade®

Drug: CABAZITAXEL
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Jevtana®

Drug: OXALIPLATIN
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Names:
  • 1-OHP
  • L-OHP
  • oxalatoplatin
  • oxaliplatinum
  • Eloxatin®

Drug: FLUOROURACIL
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Names:
  • 5-fluorouracil
  • 5-FU
  • Adrucil™
  • Carac™
  • Efudex™
  • Efudix™

Drug: FOLINIC ACID
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Names:
  • calcium folinate
  • citrovorum factor
  • Leucovorin®

Drug: CARBOPLATIN
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Paraplatin

Drug: PANOBINOSTAT
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Farydak®

Drug: VORINOSTAT
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Zolinza®

Drug: PEMBROLIZUMAB
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Keytruda™

Drug: BEVACIZUMAB
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Names:
  • rhuMAb VEGF
  • Avastin®

Drug: IPILIMUMAB
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Yervoy®

Drug: NIVOLUMAB
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Opdivo®

Drug: EVEROLIMUS
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Afinitor

Drug: SIROLIMUS
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Rapamune®

Drug: CELECOXIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Celebrex®

Drug: OLAPARIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Lynparza®

Drug: AFATINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Gilotrif®

Drug: CABOZANTINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: CABOMETYX®

Drug: SORAFENIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Nexavar®

Drug: DASATINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Sprycel®

Drug: ERLOTINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Tarceva®

Drug: IDELALISIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Zydelig®

Drug: IMATINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Gleevac®

Drug: LENVATINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Lenvima®

Drug: PERTUZUMAB
Given IV (infusion); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Perjeta®

Drug: PONATINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Iclusig®

Drug: RUXOLITINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Jakafi®

Drug: SUNITINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Sutent®

Drug: TRAMETINIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Mekinist®

Drug: VEMURAFENIB
Given PO (orally); Initial dosing and any subsequent dose modifications will be guided by manufacturer package inserts and institutional dosing guidelines; Drug will be combined with another agent from the list.
Other Name: Zelbraf®




Primary Outcome Measures :
  1. Ability for participants to start on-study treatment based upon on-study measurement after experiencing progressive disease [ Time Frame: Within 2 months following progressive disease (PD) from standard of care therapy. ]
    Measured as the number of participants to complete first dose of first SMMART therapy (Therapy #1).


Secondary Outcome Measures :
  1. Incidence of Grade 3+ toxicities attributable to assigned study drug(s). [ Time Frame: 30 days post completion of SMMART Therapy #1 (up to 6 months) ]
    Measured with NCI CTCAE Criteria version 5.0

  2. Response rate for BCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Tumor response will be determined per the investigators' assessment, according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is defined as the sum of Partial response (Pr) and Complete response (CR) divided by the number of all treated participants.

  3. Response rate for PCa cohort. [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Tumor response will be determined per the investigators' assessment, according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is defined as the sum of Partial response (Pr) and Complete response (CR) divided by the number of all treated participants.

  4. Response rate for PanCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Tumor response will be determined per the investigators' assessment, according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is defined as the sum of Partial response (Pr) and Complete response (CR) divided by the number of all treated participants.

  5. Response rate for AML cohort. [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Assessment of clinical response will be made according to revised recommendations of the International Working Group (IWG) for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic Trials in Acute Myeloid Leukemia. Defined as the sum of Partial remission (Pr) and Complete response (CR), CR with incomplete recovery (CRi), Cytogenetic Complete Remission (CRc), molecular CR (CRm), divided by the number of all treated participants.

  6. Progression Free Survival (PFS) for BCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or death from any cause.

  7. PFS for PCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or death from any cause.

  8. PFS for PanCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or death from any cause.

  9. PFS for AML cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or CR with incomplete recovery (Cri), Cytogenetic Complete Remission (CRc), molecular CR (CRm), or death from any cause

  10. Overall survival (OS) for entire treatment cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.

  11. OS for BCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.

  12. OS for PCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.

  13. OS for PanCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.

  14. OS for AML cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.

  15. Disease specific survival (DSS) for entire treatment cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 12 months) ]
    DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.

  16. DSS for PCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 12 months) ]
    DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.

  17. DSS for PanCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 12 months) ]
    DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.

  18. DSS for AML cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 12 months) ]
    DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.

  19. Determine Time to Decline (TTD) for BCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.

  20. Determine Time to Decline (TTD) for PCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.

  21. Determine Time to Decline (TTD) for PanCa cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.

  22. Determine Time to Decline (TTD) for AML cohort [ Time Frame: Completion of SMMART Therapy #1 (up to 6 months) ]
    Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent document.
  • Participants ≥ 21 years old at time of informed consent. Both men and women and members of all races and ethnic groups will be included.
  • Participants, both men and women, must agree to use an adequate method of contraception prior to Study entry, for the duration of Study participation, and for 4 months after completion of Study.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of Study drug administration.
  • Participants must have histologically documented BCa, PCa, or PanCa, or pathologically documented AML.
  • Participants with BCa, PCa, or AML must have progressed following standard therapy, as described in detail below for each of these diseases. Patients with PanCa will be eligible irrespective of prior treatment, inclusive of those who have not received any prior treatment. Participants who due to medical issues cannot receive other standard therapy that has been shown to prolong survival will be eligible, if other eligibility criteria are met.
  • Participants in BCa, PCa, or PanCa cohorts must have metastatic disease.

    1. For BCa and PanCa and for PCa participants with soft tissue disease, this is defined by at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan, per RECIST (v1.1).
    2. For PCa, participants with lesions on a bone scan that are considered distinctly metastatic will also be included.
  • Participants in AML cohort must have pathologically confirmed AML per WHO diagnostic criteria and have their bone marrow biopsy and aspirate reviewed at OHSU.
  • Participants in BCa, PanCa, and PCa cohorts, must have lesions meeting the above criteria also and must be amenable to image guided or direct vision biopsy.
  • Participants must not currently be receiving any other investigational agents.
  • Participants must have ECOG performance status ≤ 1 (Karnofsky ≥ 80%) and a physician assessed life expectancy of ≥ 6 months.
  • Participants must have adequate organ function (defined in protocol) at time of registration and within 4 weeks prior to initiating on-protocol treatment.
  • Any prior therapy, radiotherapy (except palliative radiation therapy of 30 Gy or less), or major surgery must have been completed ≥ 4 weeks prior to start of treatment. All adverse events due to prior therapy have resolved to a Grade 1 or better (except alopecia and lymphopenia and hematologic toxicity in AML) by start of treatment. Palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment. The radiotherapy must not be to a lesion that is included as measurable disease.
  • All potential participants must be discussed with and specifically approved by the Study PI.

CANCER SPECIFIC INCLUSION CRITERIA: Breast Cancer (BCa)

  • Participants must have progressive disease.
  • Participants considered to have hormone receptor positive disease and/or those considered to have HER2 positive disease must have failed all prior therapies considered to be standard of care based upon hormone receptor and HER2 expression status.
  • Participants who are considered to have failed hormone or HER2 directed therapy but are still maintained on those respective lines of agents per standard of care practice will be considered on a case-by-case basis for participation in the Study while still receiving such agents.
  • Participants must be about to begin chemotherapy.
  • Participants with triple negative breast cancer (TNBC) who are about to begin a course of chemotherapy are eligible.

CANCER SPECIFIC INCLUSION CRITERIA: Prostate Cancer (PCa)

  • Participants must have progressive disease.
  • Participants must have failed at least one line of hormone therapy in the setting of castrate resistant disease (i.e., individuals must have failed initial androgen deprivation therapy as well as one line of another hormone therapy).
  • Participants must have castrate levels of testosterone and are about to begin chemotherapy.

CANCER SPECIFIC INCLUSION CRITERIA: Pancreatic Cancer (PanCa)

  • Participants with newly diagnosed metastatic disease and are beginning first-line treatment with a course of chemotherapy are eligible.

    1. Participants who have failed prior chemotherapy for metastatic disease and are about to begin another line of chemotherapy will be considered on a case-by-case basis.
    2. Adjuvant or neo-adjuvant chemotherapy given in the context of local disease will not count towards number of regimens for metastatic disease.

CANCER SPECIFIC INCLUSION CRITERIA: Acute Myelogenous Leukemia (AML)

  • Participants must have primary refractory or relapsed AML with persistent disease after receiving two intensive regimens (also termed induction regimens).
  • Participants who are considered older (i.e., over 60), will be eligible and do not have to meet the above requirements. Such individuals will evaluated on a case by case basis, but will have failed an initial induction regimen and are not considered bone marrow transplant candidates.
  • Participants may be on hydroxyurea for purposes of controlling WBC counts at the time of Study entry (i.e., time of Biopsy #1) and may remain on it during the screening part of the study.

    1. Participants may remain on hydroxyurea through the first two cycles of SMMART therapy. It is standard practice to take this approach with refractory AML participants entering onto trials of experimental agents. Continuation of hydroxyurea beyond first two cycles may be allowed on a case by case basis. Hydroxyurea will not count as a SMMART Study drug, i.e., they can remain on hydroxyurea while receiving SMMART Drug A plus Drug B. Co-administration of hydroxyurea will be appropriately documented on treatment plans and relevant case report forms.

Exclusion Criteria:

  • Participants with metastases to the central nervous system that are considered uncontrolled and/or were diagnosed within the past 4 weeks of screening for this Study.
  • Participants with certain subtypes of cancer will be excluded. The following list provides examples but is not all inclusive, and individual situations will be handled on a case-by-case basis: neuroendocrine PanCa, small cell PCa, unusual subtypes of BCa, acute promyelocytic leukemia (APL).
  • Participants cannot have an active malignancy of another cancer. Those with a history of prior malignancy will be considered on a case-by-case basis. Guiding examples for those who can be enrolled include: individuals who have been disease free for >5 years; individuals who are considered to have a high likelihood of being cured (e.g., prior history of stage 1 rectal cancer and currently otherwise disease free); adequately treated localized non-melanomatous skin cancer.
  • Participants cannot be on other forms of anti-cancer therapy at the same time, except as described within this protocol. There must be at least washout period that accounts for 5 half-lives of last therapy.

    1. Participants with PCa will continue treatment with androgen deprivation therapy, either by prior castration or treatment with LHRH antagonists or agonists, as is standard practice.
    2. Participants with BCa who are HER2 positive may continue to receive anti-HER2 therapy per standard practice guidelines, while participants who are hormone receptor positive may continue to receive hormone therapy per standard practice guidelines.
    3. Participants with AML may continue to receive hydroxyurea for two cycles of SMMART therapy, as described in this protocol.
  • Participants with medical conditions, inclusive of psychiatric, that in the opinion of the investigators would jeopardize the patient or the Study will be excluded.
  • Participants that are pregnant or breast feeding.

CANCER SPECIFIC EXCLUSION CRITERIA: Breast Cancer (BCa)

  • Participants who have already received 3 or more treatment courses with cytotoxic agents for metastatic disease typically constitute individuals with compromised organ function and performance status and will generally not be considered eligible.

    1. Recognizing that this is not always the case, such individuals will be considered on a case-by-case basis.
    2. Adjuvant chemotherapy will not count towards this number of treatment courses.

CANCER SPECIFIC EXCLUSION CRITERIA: Prostate Cancer (PCa)

  • Participants who have already received 2 or more courses with cytotoxic agents typically constitute individuals with compromised organ function and performance status and will generally not be considered eligible.

    1. Recognizing that this is not always the case, such individuals will be considered on a case-by-case basis.
    2. Chemotherapy administered up front in newly diagnosed metastatic disease (i.e., at the time of initiation of androgen deprivation therapy, considered standard of care) will not count towards this number.

CANCER SPECIFIC EXCLUSION CRITERIA: Acute Myelogenous Leukemia (AML)

  • Participants must not be planning to undergo bone marrow transplant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878524


Contacts
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Contact: Kiara Siex, MPH 503-418-3115 siex@ohsu.edu

Locations
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United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Kiara Siex, MPH    503-418-3115    siex@ohsu.edu   
Principal Investigator: Raymond Bergan, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
Investigators
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Principal Investigator: Raymond Bergan, MD OHSU Knight Cancer Institute

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Responsible Party: Raymond Bergan, MD, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03878524     History of Changes
Other Study ID Numbers: STUDY00015588
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Venetoclax
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Folic Acid
Sirolimus
Celecoxib
Bevacizumab
Nivolumab
Pembrolizumab
Ipilimumab
Pertuzumab
Sunitinib
Carboplatin
Oxaliplatin
Fluorouracil
Everolimus
Sorafenib
Erlotinib Hydrochloride
Bortezomib
Imatinib Mesylate
Dasatinib
Olaparib
Vorinostat
Palbociclib
Trametinib
Vemurafenib