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Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer

NCT02178436 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-07

Study results available
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Summary

This partially randomized phase Ib/II trial studies the side effects and best dose of selinexor when given together with gemcitabine and nab-paclitaxel, and to see how well they work in treating patients with pancreatic cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as selinexor, gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Stage IV Pancreatic Cancer

Interventions

DRUG

gemcitabine hydrochloride

Given IV

DRUG

Selinexor

Given IV

OTHER

Pharmacological Study

Correlative studies

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nab paclitaxel

Given IV

Sponsors & Collaborators

  • Mohammed Najeeb Al Hallak

    lead OTHER

Principal Investigators

  • Mohammed N Al Hallak, M.D. · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2021-11-27
Completion
2023-04-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02178436 on ClinicalTrials.gov