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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 : Recruiting
First Posted : January 7, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

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.

This study is currently closed for enrollment for patients with relapsed/refractory multiple myeloma (MM), metastatic or colorectal cancer (mCRC), and metastatic castration resistant prostate cancer (mCRPC).


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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 119 participants
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 2019
Estimated Study Completion Date : June 2019


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 Resistance Prostate Cancer (mCRPC) - CLOSED TO ENROLLMENT

Higher Risk Myelodysplastic Syndrome (MDS) - OPEN TO ENROLLMENT

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

Drug: KPT-8602



Primary Outcome Measures :
  1. Evaluate dose limiting toxicities of KPT-8602 [ Time Frame: From first dose through Cycle 1- 28 days ]


Information from the National Library of Medicine

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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.

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


Contacts
Contact: Jatin Shah, MD jshah@karyopharm.com
Contact: Sharon Shacham, PhD

Locations
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Rachid Baz, MD    813-745-8212    Rachid.Baz@Moffit.org   
Principal Investigator: Rachid Baz, MD         
United States, New Jersey
John Theurer Cancer Center at Hackensack UMC Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Noa Biran, MD    551-996-8704    NBiran@HackensackUMC.org   
Principal Investigator: Noa Biran, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Sangmin Lee, MD    646-962-7200    sal9053@med.cornell.edu   
Principal Investigator: Sangmin Lee, MD         
United States, Ohio
Ohio State University, The James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: John Hays, MD, PhD       John.Hays@osumc.edu   
Principal Investigator: John Hays, MD, PhD         
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center Clinical Research Unit Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dan Vogl, MD    215-614-0037    Dan.Vogl@uphs.upenn.edu   
Principal Investigator: Dan Vogl, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Robert Cornell, MD,MS    615-936-8422    robert.f.cornell@vanderbilt.edu   
Principal Investigator: Robert Cornell, MD,MS         
Canada, Ontario
Princess Margaret Cancer Research Completed
Toronto, Ontario, Canada
Canada, Quebec
MUHC GLEN Site Cedars - Cancer Centre Completed
Montréal, Quebec, Canada
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
Study Director: Jatin Shah, MD Karyopharm Therapeutics Inc

Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02649790     History of Changes
Other Study ID Numbers: KCP-8602-801
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karyopharm Therapeutics Inc:
Multiple Myeloma
Karyopharm
KPT-8602
MM
Phase 1
Relapsed/ Refractory Multiple Myeloma
Myelodysplastic Syndrome
MDS
Metastatic Castration Resistant Prostate Cancer
mCRPC
CRC
Metastatic Colorectal Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Colorectal Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
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