Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

Summary

This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy or immunotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.

Conditions

• Advanced Malignant Solid Neoplasm
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Fallopian Tube Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Renal Cell Carcinoma
• Ovarian Carcinoma
• Pathologic Stage III Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IIID Cutaneous Melanoma AJCC v8
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Primary Peritoneal Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8
• Triple-Negative Breast Carcinoma
• Unresectable Lung Non-Small Cell Carcinoma
• Unresectable Melanoma
• Unresectable Renal Cell Carcinoma

Interventions

DRUG

Capecitabine

Given PO

DRUG

Carboplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Eribulin

Given IV

DRUG

Fluorouracil

Given IV

BIOLOGICAL

Ipilimumab

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Olaparib

Given PO

DRUG

Oxaliplatin

Given IV

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Pemetrexed

Given IV

DRUG

Selinexor

Given PO

DRUG

Topotecan

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Aung Naing, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-26

Primary Completion

2024-09-16

Completion

2024-09-16

FDA Drug

Yes

Countries

• United States

Study Locations