CompletedPhase 1/2

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

United States, Canada, China277 participantsStarted 2016-01

Plain-language 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 participants with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), higher risk myelodysplastic syndrome (HRMDS), acute myeloid leukemia (AML) and newly diagnosed intermediate/high-risk MDS. Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent signed prior to any screening procedures and in accordance with federal, local, and institutional guidelines.
. Age ≥ 18 years.
. Adequate hepatic function:
. total bilirubin ≤ 2 times the upper limit of normal (ULN) (except participants with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 4 times ULN),
. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (except participants with known liver involvement of their tumor who must have their AST and ALT ≤ 5.0 times ULN).
. Adequate renal function: estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) × Mass (kg)/(72 × creatinine mg/dL); multiply by 0.85 if female.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A1, A2, B, C, D, E, F: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Timeframe: Approximately 4 weeks

Part A1, A2, B, C, D, E, F: Overall Response Rate (ORR)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Duration of Response (DOR)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Progression-free Survival (PFS)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Overall Survival (OS)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Clinical Benefit Rate (CBR)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Duration of Clinical Benefit Rate (CBR)

Timeframe: Approximately 8 years

Trial details

NCT IDNCT02649790

SponsorKaryopharm Therapeutics Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-31

View on ClinicalTrials.gov More Relapsed/Refractory Multiple Myeloma (RRMM) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent signed prior to any screening procedures and in accordance with federal, local, and institutional guidelines.
. Age ≥ 18 years.
. Adequate hepatic function:
. total bilirubin ≤ 2 times the upper limit of normal (ULN) (except participants with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 4 times ULN),
. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (except participants with known liver involvement of their tumor who must have their AST and ALT ≤ 5.0 times ULN).
. Adequate renal function: estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) × Mass (kg)/(72 × creatinine mg/dL); multiply by 0.85 if female.

What they're measuring

Part A1, A2, B, C, D, E, F: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Timeframe: Approximately 4 weeks

Part A1, A2, B, C, D, E, F: Overall Response Rate (ORR)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Duration of Response (DOR)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Progression-free Survival (PFS)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Overall Survival (OS)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Clinical Benefit Rate (CBR)

Timeframe: Approximately 8 years

Part A1, A2, B, C, D, E, F: Duration of Clinical Benefit Rate (CBR)

Timeframe: Approximately 8 years

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria