Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02178436
Other study ID # 2013-133
Secondary ID NCI-2014-01249
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 31, 2014
Est. completion date April 5, 2023

Study information

Verified date November 2023
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
gemcitabine hydrochloride
Given IV
Selinexor
Given IV
Other:
Pharmacological Study
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Drug:
Nab paclitaxel
Given IV

Locations

Country Name City State
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Stony Brook University Cancer Center Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Mohammed Najeeb Al Hallak

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Gene Expression (Including Forkhead Box Protein O, I-kappaB, Cyclin-dependent Kinase Inhibitor 1B, Par4 and Phosphorylated Signal Transducer and Activator of Transcription 3) (Phase II) Seven patients in each group will yield a two-sided 90% confidence interval with a distance from the mean change to the limits of 0.75 standard deviation units. A two-sided p-value of 0.10 will be used for all analyses. Baseline to up to 2 years
Primary Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib) MTD is defined as the lowest dose for which less than a third of patients experience a dose limiting toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. 28 days
Primary Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03 The reported output is the proportion of patients that had a toxic event along with the associated 90% Wilson's confidence interval. Up to 2 years
Primary Overall Survival (Phase II) Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. Up to 7 months post treatment initiation
Secondary Effects the Study Drug Combination Has on Participants Pharmacodynamics of selinexor in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation Day 1 of course 1 (before selinexor administration, 1, 2, 4 and 8 hours after selinexor administration) and days 2, 3 and 8
Secondary Proportion of Patients With a Response Point and 90% Wilson's confidence intervals will be estimated to describe response rate. If the best observed clinical response was complete response or partial response, we consider that the patient responded. Up to 2 years
Secondary Progression Free Survival (Phase II) Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. Both progression and death are considered events for this analysis. Up to 2 years
See also
  Status Clinical Trial Phase
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT02005315 - A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer Phase 1
Completed NCT01453153 - Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer Phase 1/Phase 2
Completed NCT01064622 - Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer Phase 1/Phase 2
Completed NCT00095966 - Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01647828 - A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer Phase 1/Phase 2
Terminated NCT01555489 - Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca Phase 2
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT01232829 - Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer Phase 2
Completed NCT00735917 - Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer Phase 2
Completed NCT02896907 - Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery Early Phase 1
Completed NCT02307539 - Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer N/A
Completed NCT02050178 - Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer Phase 1
Completed NCT01488552 - Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT01222689 - Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Completed NCT00397787 - Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine Phase 2
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Completed NCT01893801 - Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA Phase 1/Phase 2