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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Mohammed Najeeb Al Hallak
Study ID
NCT02178436
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gemcitabine hydrochloride — DRUG
    Given IV
  • Selinexor — DRUG
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nab paclitaxel — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Oct 31, 2014
Status verified
Nov 2023
Primary completion
Nov 27, 2021
Completion
Apr 5, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I: Phase Ib (gemcitabine, nab-paclitaxel, selinexor)
    Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group II: Phase II Group I (gemcitabine, selinexor)
    Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
  • Experimental: GroupIII: Phase II Group II (gemcitabine, selinexor)
    Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib) [ Time Frame: 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Stony Brook University Cancer CenterStony BrookNew York11794-

Find similar trials in Detroit, MI

By research site
Barbara Ann Karmanos Cancer Institute· Detroit, MIStony Brook University Cancer Center· Stony Brook, NY

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