Clinical Trials /

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

NCT02649790

Description:

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).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title:Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed/Refractory Multiple Myeloma
  • Official Title: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 Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: KCP-8602-801
  • NCT ID: NCT02649790

Trial Conditions

  • Multiple Myeloma

Trial Interventions

DrugSynonymsArms
KPT-8602KPT-8602

Trial Purpose

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 MM.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
KPT-8602Experimental5 mg starting dose
  • KPT-8602

Eligibility Criteria

Inclusion Criteria

- Evidence of disease progression:

- Symptomatic relapsed or refractory requiring current treatment.

- Previously treated with ≥ 3 prior regimens (lines of therapy) that included at least one of each of the following: alkylating agent, immunomodulatory drug, proteasome inhibitor, and a steroid.

- Must be refractory to most recent anti-cancer regimen.

- Must have measurable disease defined by one of the following:

- Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA. If SPEP is felt to be unreliable for routine Mprotein measurement (e.g., for patients with IgA MM), then quantitative Ig levels by nephelometry or turbidometry are acceptable; or

- Urinary M-protein excretion at least 200 mg/24 hours; or

- Serum Free Light Chain (Serum FLC) whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio.

- Eastern Cooperative Oncology Group performance status of ≤ 1.

Exclusion Criteria

- Time since the last prior therapy:

- Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including investigational anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1.

- Palliative steroids for disease related symptoms are allowed up to 3 days prior to Cycle 1 Day 1.

- Active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation.

- Active central nervous system malignancy. Patients who have only had prophylactic intrathecal or intravenous chemotherapy against central nervous system disease are eligible.

- Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-8602.

- Prior exposure to XPO1 inhibitors.

- Life expectancy of ≥ 4 months.

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate dose limiting toxicities of KPT-8602
Time Frame:From first dose through Cycle 1- 28 days
Safety Issue:Yes
Description:

Secondary Outcome Measures

Trial Keywords

  • Multiple Myeloma
  • Karyopharm
  • KPT-8602
  • MM
  • Phase 1
  • Relapsed/refractory Multiple Myeloma