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



Status:Recruiting
Conditions:Prostate Cancer, Colorectal Cancer, Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 2016
End Date:June 2019
Contact:Jatin Shah, MD
Email:jshah@karyopharm.com

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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

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).


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.
We found this trial at
7
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Robert Cornell, MD,MS
Phone: 615-936-8422
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Columbus, Ohio 43210
Principal Investigator: John Hays, MD, PhD
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Hackensack, New Jersey 07601
Principal Investigator: Noa Biran, MD
Phone: 551-996-8704
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New York, New York 10021
Principal Investigator: Sangmin Lee, MD
Phone: 646-962-7200
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421 Curie Boulevard
Philadelphia, Pennsylvania 19104
Principal Investigator: Dan Vogl, MD
Phone: 215-614-0037
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Tampa, Florida 33612
Principal Investigator: Rachid Baz, MD
Phone: 813-745-8212
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610 University Avenue
Toronto, Ontario M5G 2M9
Principal Investigator: Christine Chen, MD, MHPE, FRCPC
Phone: 416-946-4501
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Toronto,
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