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Selinexor in Combination With Ixazomib for the Treatment of Advanced Sarcoma

NCT03880123 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-11-27

No results posted yet for this study

Summary

The main purpose of this study is to establish a safe and tolerable dose combination (the "maximum tolerated dose") of selinexor and ixazomib when used together for the treatment of patients with certain types of advanced sarcoma. The study will enroll patients with advanced dedifferentiated liposarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma and Ewing sarcoma. Future studies to further evaluate the safety and anti-cancer efficacy of this treatment for sarcoma will use the dose combination determined in this study.

Conditions

  • Liposarcoma
  • Malignant Peripheral Nerve Sheath Tumors
  • Alveolar Soft Part Sarcoma
  • Ewing Sarcoma
  • Sarcoma

Interventions

DRUG

Selinexor

Selinexor will be taken orally on Days 1, 8, 15, and 22 of each cycle at the following dose levels (DLs): DL 1: 40 mg; DL 2: 60 mg; DL 3: 80 mg; DL 4: 100 mg The selinexor product is provided as 20 mg tablets in wallet-sized blister packs. Selinexor should be taken together with ixazomib.

DRUG

Ixazomib

Ixazomib will be taken orally on Days 1, 8, and 15 of each cycle at the same dose level: 4 mg. The ixazomib product is provided in strengths of 4.0, 3.0, and 2.3 mg capsules as the active boronic acid. Ixazomib should be taken on an empty stomach (no food or drink) at least 1 hour before or at least 2 hours after food.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • Matthew Ingham

    lead OTHER

Principal Investigators

  • Matthew Ingham, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2020-11-24
Completion
2020-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880123 on ClinicalTrials.gov