Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of CRLX101, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769962
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE May 11, 2016
First Posted Date  ICMJE May 12, 2016
Last Update Posted Date May 21, 2020
Actual Study Start Date  ICMJE May 9, 2016
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2019)
  • Expansion: To determine overall response rate of CRLX101 plus olaparib in patients with mCRPC [ Time Frame: 12 weeks ]
    Determine if slightly more than 50% of patients may be identified as being without progression by 12 weeks.
  • Expansion: To determine overall response rate of CRLX101 plus olaparib in patients with urothelial carcinoma [ Time Frame: 8 weeks ]
    Best response recorded from the start of the treatment until disease progression/recurrence.
  • Phase I: Determine the MTD/RP2D of CRLX101 plus olaparib in patients with refractory cancers. [ Time Frame: 28 days ]
    Number of DLTs during the first cycle.
  • Expansion: Determine the PFS rate in the combination of olaparib plus CRLX101 at 16 weeks in SCLC patients. [ Time Frame: 16 weeks ]
    Determine if slightly more than 50% of patients may be identified as being without progression by 16 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Phase I: Determine the MTD/RP2D of CRLX101 plus olaparib in patients with refractory cancers. [ Time Frame: 28 days ]
  • Phase II Chemo Resistant: Determine the PFS rate in the combination of olaparib plus CRLX101 at 16 weeks in SCLCpatients with chemo resistant relapse. [ Time Frame: 16 weeks ]
  • Phase II Chemo Sensitive: Determine the PFS rate in thecombination of olaparib plus CRLX101 at 16 weeks in SCLCpatients with chemo sensitive relapse. [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Evaluate the pharmacokinetic profile of CRLX101 (both the total drug and released camptothecin) and olaparib in plasma [ Time Frame: Cycles 1 and 6 ]
    Drug levels in blood
  • Evaluate the pharmacodynamic (PD) activity of CRLX101 in blood,surrogate tissue and tumor biopsy specimens. [ Time Frame: Baseline, Cycle 1, then every 2cycles, and at progression ]
    Drug levels in blood.
  • Determine the duration of response (DOR), overall survival (OS), andprogression-free survival (PFS) of the combination [ Time Frame: Every 3 months post-treatment ]
    DOR is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. OS is determined from the start of treatment until death. PFS is defined as the duration of time from start of treatment to time of progression ordeath, whichever occurs first.
  • Explore further the safety of the combination table oftoxicities including type, severity, time of onset, time of resolution and probable association with study regimen [ Time Frame: Start of treatment through 30 days post last dose ]
    List of adverse event frequency
  • To determine safety in patients on expansion cohorts: table of toxicities including type, severity, time of onset, time of resolution and probable association with study regimen [ Time Frame: Start of treatment through 30 days post last dose ]
    List of adverse event frequency
  • To determine progression-free survival (PFS) on expansion cohorts [ Time Frame: Every 3 months post-treatment ]
    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
  • To determine duration of response and PSA on mCRPC expansion cohort [ Time Frame: Every 12 weeks until progression ]
    PSA levels in blood
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Evaluate the pharmacokinetic profile of CRLX101 (both the total drug and released camptothecin) and olaparib in plasma [ Time Frame: Cycles 1 and 6 ]
  • Evaluate the pharmacodynamic (PD) activity of CRLX101 in blood,surrogate tissue and tumor biopsy specimens. [ Time Frame: Baseline, Cycle 1, then every 2cycles, and at progression ]
  • Determine the duration of response (DOR), overall survival (OS), andprogression-free survival (PFS) of the combination [ Time Frame: Every 3 months post-treatment ]
  • Explore further the safety of the combination [ Time Frame: Ongoing ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of CRLX101, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer
Official Title  ICMJE A Phase I/II Trial of CRLX101, a Nanoparticle Camptothecin With Olaparib in Patients With Relapsed/Refractory Small Cell Lung, Bladder and Prostate Cancers
Brief Summary

Background: CRLX101 consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or nanoparticle drug conjugate travels through the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule. Olaparib is a drug that may stop cancer cells from repairing the DNA damage caused by chemotherapy. Researchers want to see how safe it is to give CRLX101 and olaparib together and to see how well the combination treats a specific type of lung cancer called small cell lung cancer (SCLC).

Objectives:

To test the safety and maximum dose of CLRX101 and olaparib together. To test how well they treat small cell lung cancer.

Eligibility:

Adults 18 and older with small cell lung cancer.

Design:

Participants will be screened with standard cancer care tests.

Participants will get the 2 study drugs in 28-day cycles. CRLX101 will be given every 2 weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most days. Participants will keep a pill diary.

For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits.

At study visits, participants may have:

Blood and hair samples taken

History and Physical exam

Questions about health and side effects

Pregnancy test

Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. .

CT scan

Injection of CRLX101 (twice per cycle)

<TAB>Olaparib prescription <TAB>

Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will have a physical exam and blood tests. They may have a tumor biopsy. The study team will call the patient every 3 months for follow up after completing the study treatment.

Detailed Description

Background:

  • Small cell lung cancer (SCLC) is an aggressive cancer with a poor prognosis.
  • Although highly responsive to chemotherapy initially, SCLC relapses quickly and becomes refractory to treatment within a few months.
  • Urothelial Carcinoma (UC) of the Bladder is the fourth most common malignancy in men and the ninth most common in women.
  • Prostate cancer is the most common cancer among men in the United States. While prostate cancer is initially responsive to androgen deprivation therapy (ADT), the median duration of sensitivity is 24-36 months. Moreover, patients develop resistance to current treatment options.
  • The use of PARP inhibitors in combination with chemotherapy builds upon pre-clinical data in lung cancer and other cancers supporting the notion that PARP inhibitors potentiate the effect of DNA damaging therapies.
  • Despite their highly synergistic activity in preclinical models, human studies combining PARP inhibitors and camptothecins have not translated into clinical benefit due to enhanced toxicity with the combination.
  • One approach to improve ability to combine camptothecins with agents that sensitize their activity like PARP inhibitors is to use alternative formulations that minimize toxicity to the normal tissues.
  • CRLX101 is a nanoparticle drug conjugate composed of 20 (S)-camptothecin (a potent and highly selective topoisomerase I inhibitor) conjugated to a linear, cyclodextrinpolyethylene glycol-based polymer.
  • Olaparib is a PARP inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Olaparib has an established safety profile and it is under investigation in a number of different cancers.

Objectives:

  • Phase I: To determine the MTD/ recommended Phase 2 dose (RP2D) of CRLX101 in combination with olaparib in patients with refractory cancers
  • Phase II: To determine the antitumor activity of olaparib plus CRLX101 with respect to progression free survival at 16 weeks in SCLC patients with resistant or sensitive relapse
  • Expansion Cohorts: To determine overall response rate of CRLX101 plus olaparib in

patients with mCRPC and urothelial carcinoma

Eligibility:

Phase I:

  • Male or female adult patients greater than or equal to 18 years of age
  • Histologically or cytologically confirmed, advanced solid tumor that is refractory to

standard therapy and/or for whom no further standard therapy is available

-ECOG Performance Status of 0, 1 or 2

Phase II:

  • Male or female patients greater than or equal to 18 years old
  • Have a pathologically (histology or cytology) confirmed diagnosis of SCLC
  • Disease progression on or after at least one platinum-based standard chemotherapy

regimen and/or an immune-checkpoint inhibitor for either limited or extensive stage

disease.

  • Have measurable disease per RECIST 1.1
  • ECOG performance status of 0, 1 or 2

Phase II Expansion Cohorts:

-Have a pathologically (histology or cytology) confirmed diagnosis of urothelial

carcinoma or metastatic, progressive, castrate resistant prostate cancer (mCRPC)

-Disease progression on or after at least one platinum-based standard chemotherapy

regimen and/or an immune-checkpoint inhibitor (except prostate cohort)

  • Have measurable disease per RECIST 1.1 (except prostate cohort)
  • Prior treatment with enzalutamide and/or abiraterone (prostate cancer cohort only)
  • Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]) (Prostate

cohort only)

Design:

  • Patients meeting eligibility criteria will receive CRLX101 (IV Q 2weeks) plus olaparib (PO BID days 3-13 and days 17-26 administered in 28 day cycles, until disease progression or development of intolerable side effects. The MTD of the combination will be used in Phase II.
  • Patients in Phase II will receive, the RP2D at DL4R CRLX101 12mg/m2 and olaparib 250mg BID.
  • Blood, tumor and hair samples will be collected at multiple time points for PK, PD analyses. Hair sample collection is optional. Tumor biopsies are optional for SCLC and UC patients and mandatory for mCRPC patients (only baseline biopsy is mandatory).
  • Toxicity will be graded according to CTCAE version 4.0.
  • Tumor assessments will be made using CT scans (chest, abdomen and pelvis) at baseline and after every 2 cycles (3 cycles for mCRPC) according to RECIST version 1.1.
  • After discontinuation of study treatment, follow-up for survival will be carried out every 3 months.
  • The maximum number of patients on the phase I portion of the trial is 30, the SCLC cohort in phase II may accrue up to 27 evaluable patients, urothelial carcinoma expansion cohort may accrue up to 34 patients and mCRPC may accrue up to 25 patients. Thus, the maximum number of evaluable patients who may enroll on this trial is 116. In order to allow for a small number of in-evaluable patients, the accrual ceiling will be set at 123.
  • It is anticipated that approximately 1 to 2 patients per month may enroll onto this trial; the trial is expect to complete accrual in 6-8 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urothelial Carcinoma
  • Urothelial Cancer
  • Lung Neoplasms
  • Small Cell Lung Cancer
  • Prostate Cancer
Intervention  ICMJE
  • Drug: CRLX101

    CRLX101 IV Q 2weeks Day 1 and Day 15, administered in 28 day cycles, until disease progression or development of intolerable side effects

    Plus olaparib (PO days 3-13* and days 17-26*) administered in 28 day cycle, until disease progression or development of intolerable side effects.

    P1: Dose Escalation P2: RP2

    (* On days 13 and 26, only one dose of olaparib will be administered in the morning)

  • Drug: olaparib

    olaparib (PO days 3-13* and days 17-26* administered in 28 day cycles, until disease progression or development of intolerable side effects

    Plus CRLX101 (IV Q 2weeks, Day 1 and Day 15) administered in 28 day cycles, until disease progression or development of intolerable side effects

    P1: Dose Escalation P2: RP2D

    (* On days 13 and 26, only one dose of olaparib will be administered in the morning)

Study Arms  ICMJE
  • Experimental: Phase I
    CRLX101 + olaparib CRLX101 (IV Q 2wks Days 1, 15) + olaparib (PO Days 3- 13* and 17-26*) q 28 days
    Interventions:
    • Drug: CRLX101
    • Drug: olaparib
  • Experimental: Phase II
    CRLX101 + olaparib at MTD/RP2DRP2D CRLX101 + olaparib q 28 days
    Interventions:
    • Drug: CRLX101
    • Drug: olaparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2019)
123
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
75
Estimated Study Completion Date  ICMJE December 31, 2027
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:

Phase I:

  • Patients must have advanced solid tumor that is resistant or refractory to standard therapy.
  • A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry.
  • Patients do not need to have measurable disease to enroll on phase I.
  • Age greater than or equal 18 years.
  • ECOG performance status less than or equal to 2.
  • Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed.
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes greater than or equal to 3,000/mcL
    • absolute neutrophil count >1,500/mcL without growth factor support
    • platelets greater than or equal 100,000/mcL without growth factor support
    • hemoglobin greater than or equal 9 g/dL and no blood transfusion within 4 weeks OR greater than 10 g/dL and no blood transfusion within 2 weeks.
    • total bilirubin less than or equal 1.5 x ULN (unless Gilbert s Disease)
    • AST(SGOT)/ALT(SGPT) less than or equal 2.5 X institutional upper limit of normal (less than or wqual to 5X ULN if liver mets)
    • creatinine less than ULN OR
    • creatinine clearance greater than or equal 51 mL/min (calculated using the Cockroft- Gault formula) for patients with creatinine levels above institutional normal.
  • The effects of CRLX101 and olaparib on the developing human fetus are unknown. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:

    • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
    • LH and FSH levels in the post menopausal range for women under 50,
    • radiation-induced oophorectomy with last menses >1 year ago,
    • chemotherapy-induced menopause with >1 year interval since last menses,
    • or surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Negative urine pregnancy test less than or equal to 3 days prior to C1D1 (women of childbearing potential only)
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Inclusion Criteria Phase II - SCLC:

  • Age greater than or equal to18 years.
  • Patients must have histologically or cytologically confirmed diagnosis of SCLC from a CLIA-certified laboratory.
  • Have received and progressed during or after a platinum-based standard chemotherapy regimen and/or an immune-checkpoint inhibitor.
  • Patients could have received any number of therapies for relapsed or progressive disease, including re-treatment with original frontline regimen. A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry. No previous irradiation to the site of measurable or evaluable disease, unless that site had subsequent evidence of progression.
  • Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors, version (RECIST 1.1).
  • Radiographic evidence of disease progression after initial therapy should have been documented.
  • ECOG performance status less than or equal to 2.
  • Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed.
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes greater than or equal to 3,000/mcL
    • absolute neutrophil count greater than or equal to 1,500/mcL without growth factor support
    • platelets greater than or equal to 100,000/mcL without growth factor support
    • hemoglobin greater than or equal to 9 g/dL and no blood transfusion within 4 weeks OR greater than 10 g/dL and no blood transusion within 2 weeks
    • total bilirubin less than or equal to 1.5 x ULN (unless Gilbert s Disease)
    • AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal (less than or equal to 5X ULN if liver mets)
    • creatinine less than ULN OR
    • creatinine clearance greater than or equal to 51 mL/min (calculated using the Cockroft- Gault formula) for patients with creatinine levels above institutional normal.
  • The effects of CRLX101 and olaparib on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:

    • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
    • LH and FSH levels in the post menopausal range for women under 50,
    • radiation-induced oophorectomy with last menses >1 year ago,
    • chemotherapy-induced menopause with >1 year interval since last menses,
    • or surgical sterilization (bilateral oophorectomy or hysterectomy).

INCLUSION CRITERIA FOR UROTHELIAL CARCINOMA EXPANSION COHORT:

  • Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis from a CLIA-certified laboratory, with measurable disease by RECIST including lymphadenopathy and visceral metastatic disease.
  • Male or female patients greater than or equal to 18 years of age.
  • Patient must have received at least one platinum based regimen of chemotherapy and/or an immune-checkpoint inhibitor if appropriate with progressive disease.
  • Prior antiangiogenic therapy are permitted (2-week washout from therapy is required).
  • Bisphosphonates and denosumab are permitted if on a stable dose for greater than equal to 4 weeks.
  • ECOG 0 2
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes greater than or equal to 3,000/mcL
  • absolute neutrophil count greater than or equal to 1,500/mcL without growth factor support
  • platelets greater than or equal to 100,000/mcL without growth factor support
  • hemoglobin greater than or equal to 9 g/dL and no blood transfusion within 4 weeks OR hemoglobin >10 g/dL, and no blood transfusion within 2 weeks
  • total bilirubin less than or equal to 1.5 x ULN (less than or equal to 3 (SqrRoot) ULN for subjects with Gilbert s Disease)
  • AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal (less than or equal to 5X ULN if liver mets)
  • creatinine less than or equal to ULN OR
  • creatinine clearance greater than or equal to 51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.
  • PT/INR and aPTT within 1.25 X ULN institutional limits, except where a lupus anti-coagulant has been confirmed
  • The effects of CRLX101 and olaparib on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:

    • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
    • LH and FSH levels in the post menopausal range for women under 50,
    • radiation-induced oophorectomy with last menses >1 year ago,
    • chemotherapy-induced menopause with >1 year interval since last menses,
    • or surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of olaparib.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willingness to release archival tissue sample for research purposes, if available

INCLUSION CRITERIA FOR mCRPC EXPANSION COHORT:

  • Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC).
  • Documented histopathological confirmation of prostate cancer from a CLIA-certified laboratory.
  • All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.
  • Patients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose.
  • Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l])
  • Patients must have undergone bilateral surgical castration or must agree to continue on GnRH agonists/antagonists for the duration of the study.
  • ECOG performance status less than or equal to 2
  • Patients must have adequate bone marrow, hepatic, and renal function with:
  • leukocytes greater than or equal to 3,000/mcL
  • absolute neutrophil count greater than or equal to 1,500/mcL without growth factor support
  • platelets greater than or equal to 100,000/mcL without growth factor support
  • hemoglobin greater than or equal to 9 g/dL and no blood transfusion within 4 weeks OR hemoglobin > 10g/dL, and no blood transfusion within 2 weeks
  • total bilirubin less than or equal to 1.5 x ULN (less than or equal to 3 (SqrRoot) ULN for subjects with Gilbert s Disease)
  • AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal (less than or equal to 5X ULN if liver mets)
  • creatinine less than or equal to ULN OR
  • creatinine clearance greater than or equal to 51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.

    • Men must be at least 18 years of age.
    • Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation and for 120 days after last dose of study drug. Sexually active subjects and their female partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 3 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must also agree to use both a barrier method and a second method of birth control during the course of the study and for 3 months after the last dose of study drug(s). Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physi...
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linda C Sciuto, R.N. (240) 760-6117 lsciuto@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02769962
Other Study ID Numbers  ICMJE 160107
16-C-0107
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anish Thomas, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 24, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP