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Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed/Refractory Cancer Indications

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ClinicalTrials.gov Identifier: NCT02649790
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Description
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Brief Summary:

This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), and higher risk myelodysplastic syndrome (HR-MDS).

Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.


Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma (RRMM) Metastatic Colorectal Cancer (mCRC) Metastatic Castration Resistant Prostate Cancer (mCRPC) Higher Risk Myelodysplastic Syndrome (HR-MDS) Drug: KPT-8602 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-Label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound KPT-8602 in Patients With Relapsed/Refractory Cancer Indications
Actual Study Start Date : January 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: KPT-8602

Relapsed/Refractory Multiple Myeloma (RRMM) - CLOSED TO ENROLLMENT

Metastatic Colorectal Cancer (CRC) - CLOSED TO ENROLLMENT

Relapsed/Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) - CLOSED TO ENROLLMENT

Higher Risk Myelodysplastic Syndrome (MDS) - CLOSED TO ENROLLMENT

Starting dose for CRC, mCRPC, MDS is 20 mg of KPT-8602

 Drug: KPT-8602


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [ Time Frame: Approximately 4 weeks ]
    MTD will be based on the assessment of dose limiting toxicities (DLTs) during the first cycle of therapy and will be defined as the highest dose at which 1 of 6 patients, at most, experiences DLTs within Cycle 1. Dose escalation will continue until an RP2D is selected based on DLT assessment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Written informed consent obtained prior to any screening procedures and in accordance with federal, local, and institutional guidelines.

  2. Age ≥ 18 years.

    Higher Risk Myelodysplastic Syndrome (Part F):

  3. Documented diagnosis of MDS with 5-19% myeloblasts.
  4. Patients should be intermediate-2 or high-risk MDS by International Prognostic Scoring System (IPSS).
  5. Patients believed to be IPSS high risk, without clearly meeting IPSS categories above should be discussed with the medical monitor prior to enrolling.

  6. HMA refractory patients including:

    1. ≥ 2 cycles of azacitidine and/or decitabine or experimental agents (such as SGI-110 or ASTX727 or similar) with clear progressive disease (PD) (no count recovery with ≥50% increase in bone marrow blasts)

      OR

    2. ≥ 4 cycles of azacitidine and/or decitabine (or other hypomethylating therapy) with lack of improvement (no CR/CRi/PR/HI).
  7. Patients receiving a stable dose of erythropoiesis-stimulating agent (ESA) for at least 1 month at the time of study entry may continue to receive ESA.

EXCLUSION CRITERIA

Patients in All Parts of the Study:

  1. Major surgery within 4 weeks before C1D1.
  2. Impaired cardiac function or clinically significant cardiac diseases.
  3. Uncontrolled active severe systemic infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to C1D1.
  4. Patients with known symptomatic brain metastasis.

  5. Prior malignancies:

    1. Patients in All Parts of the Study: Patients with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (i.e. cervix) may enroll irrespective of the time of diagnosis.
    2. Patients with Higher Risk MDS only: Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of enrollment.

    INDICATION-SPECIFIC EXCLUSION CRITERIA

    Higher risk Myelodysplastic Syndrome (Part F):

  6. IPSS low or intermediate-1 risk MDS.
  7. Evidence of transformation to AML by World Health Organization (WHO) (≥20% blasts in bone marrow or peripheral blood).
  8. Patients receiving granulocyte-colony stimulating factor (G-CSF) or granulocyte macrophage-colony stimulating factor (GM-CSF) within the 3 weeks prior to C1D1.
Contacts and Locations
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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): NCT02649790


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, New Jersey
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Ohio
Ohio State University, The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center Clinical Research Unit
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Canada, Ontario
Princess Margaret Cancer Research
Toronto, Ontario, Canada
Canada, Quebec
MUHC GLEN Site Cedars - Cancer Centre
Montréal, Quebec, Canada
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Study Director: Jatin Shah, MD Karyopharm Therapeutics Inc
More Information
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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02649790    
Other Study ID Numbers: KCP-8602-801
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karyopharm Therapeutics Inc:
KPT-8602
Multiple Myeloma
Karyopharm
MM
Phase 1
Relapsed/ Refractory Multiple Myeloma
 Myelodysplastic Syndrome
MDS
Metastatic Castration Resistant Prostate Cancer
mCRPC
CRC
Metastatic Colorectal Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Colorectal Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Myelodysplastic Syndromes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases