NCT02178436

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

Phase Ib Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330), Gemcitabine and Nab-Paclitaxel and Phase II Study of Gemcitabine and Selinexor in Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mohammed Najeeb Al Hallak · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: 1. Phase I: To determine the recommended phase 2 dose (RP2D) of gemcitabine, nabpaclitaxel and selinexor for untreated metastatic pancreatic cancer \[COMPLETED\] 2. Phase I: To determine the safety profile of gemcitabine, nab-paclitaxel and selinexor \[COMPLETED\] 3. Phase II: To test whether the combination of gemcitabine and selinexor improves the median overall survival of patients with metastatic pancreatic cancer who have failed frontline non-gemcitabine containing regimens beyond 5.6 months (median overall survival of patient receiving gemcitabine only based on historical data. Secondary Objectives: 1. To determine objective response rate to the combination of gemcitabine and selinexor using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 2. To assess safety of selinexor in combination with gemcitabine in phase II portion of the study 3. To determine progression free survival (PFS) in patients treated with gemcitabine and selinexor 4. To determine the influence of selinexor and gemcitabine on the nuclear expression and localization of tumor suppressor gene proteins.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-10-31
• Primary completion: 2021-11-27
• Completion: 2023-04-05
• First posted: 2014-06-30
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

2 sites across 1 country: United States