Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02468557
Recruitment Status : Terminated
First Posted : June 11, 2015
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study will evaluate the safety, pharmacodynamics, pharmacokinetics (PK), and efficacy of single agent idelalisib and in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma. This study will also define the the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: Idelalisib Drug: Nab-paclitaxel Drug: mFOLFOX6 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
Study Start Date : July 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Idelalisib
Participants will receive a single dose of idelalisib.
Drug: Idelalisib
Idelalisib tablets administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Experimental: Idelalisib + nab-paclitaxel
Participants will receive escalating doses of idelalisib + nab-paclitaxel.
Drug: Idelalisib
Idelalisib tablets administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Nab-paclitaxel
Nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle

Experimental: Idelalisib + mFOLFOX6
Participants will receive escalating doses of idelalisib + mFOLFOX6.
Drug: Idelalisib
Idelalisib tablets administered orally twice daily
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: mFOLFOX6
mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 mg/m^2 or racemic leucovorin 400 mg/m^2, oxaliplatin 85 mg/m^2, bolus 5-fluorouracil 400 mg/m^2, and a 46 hour infusion of 5-fluorouracil 2, 400 mg/m^2.




Primary Outcome Measures :
  1. Adverse event profile of single agent idelalisib as measured by incidence and severity of adverse events [ Time Frame: Up to 28 days ]
  2. Laboratory abnormality profile of single agent idelalisib as measured by incidence and severity of clinical laboratory abnormalities [ Time Frame: Up to 28 days ]
  3. For idelalisib in combination with chemotherapy, incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
    Dose limiting toxicities refer to toxicities experienced during the first 28 days of treatment (Cycle 1) that have been judged to be clinically significant and at least possibly related to study treatment.


Secondary Outcome Measures :
  1. Change from baseline in FoxP3+ and CD8+ cells from tumor tissue samples as a measure of pharmacodynamics activity [ Time Frame: Up to 2 years ]
  2. Pharmacokinetic parameters (PK) profile of idelalisib and its major metabolite (GS-563117): Cmax, Ctau and AUCtau, if applicable [ Time Frame: Predose and 1.5 hours postdose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C2D1, C3D1, C5D1, and C7D1 ]
    This endpoint will measure the plasma PK profile of idelalisib and its major metabolite (GS-563117): PK parameters that will be measured include Cmax, Ctau, and AUCtau (if applicable).

  3. Overall response rate (ORR) [ Time Frame: Up to 2 years ]
    Overall response rate (ORR) is defined as the proportion of participants who achieve a Complete Response (CR) or Partial Response (PR) as assessed by response evaluation criteria in sold tumors (RECIST) v1.1.

  4. Overall survival (OS) [ Time Frame: Up to 2 years ]
    Overall survival is defined as the interval from first dose date of study drug to death from any cause.

  5. Progression free survival (PFS) [ Time Frame: Up to 2 years ]
    Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The presence of metastatic pancreatic adenocarcinoma plus 1 of the following:

    • Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
    • Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin
  • Measurable disease per RECIST v1.1
  • Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib single agent only)
  • Received one prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + mFOLFOX6 only)
  • Adequate organ function defined as follows:

    • Hepatic: Total bilirubin ≤ 1.25 x upper limit of normal (ULN) (Arm: idelalisib + nab-paclitaxel ); total bilirubin ≤1.5 x ULN (Arm: single agent idelalisib and Arm: idelalisib + mFOLFOX6); aspartate transaminase (AST) (SGOT), alanine transaminase (ALT) (SGPT) < 2.5 x ULN, and albumin > 3.0 g/dL
    • Hematological: absolute neutrophil count (ANC) > 1,500 cells/mm^3, platelet > 100,000 cells/mm^3, hemoglobin > 9.0 g/dL
    • Renal: Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance (CrCl) > 30 ml/min as calculated by the Cockcroft-Gault method
  • Able to comprehend and willing to sign the written informed consent form

Exclusion Criteria:

  • Currently or previously treated with biologic, or immunotherapy
  • Currently or previously treated with conventional chemotherapy, or other agents for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + nab-paclitaxel only)
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Known HIV infection
  • History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to enrollment, adequately treated Stage 1 or 2 non-pancreatic cancer currently in complete remission, or any other non-pancreatic cancer that has been in complete remission for ≥ 5 years
  • Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma), adenocarcinoma originating from the biliary tree or cystadenocarcinoma
  • History of serious allergic reaction, including anaphylaxis and toxic epidermal necrolysis
  • Presence of peripheral neuropathy ≥ Grade 2 (Arm: idelalisib + nab-paclitaxel and Arm: idelalisib + mFOLFOX6)
  • Documented myocardial infarction or unstable/uncontrolled cardiac disease (eg, unstable angina, congestive heart failure [New York Heart Association > Class III]) within 6 months or enrollment
  • Known hypersensitivity to idelalisib, its metabolites, or formulation excipients
  • Known hypersensitivity to nab-paclitaxel (Arm: idelalisib + nab-paclitaxel), their metabolites, or formulation excipients
  • Known hypersensitivity to 5-fluorouracil, leucovorin, or oxaliplatin (Arm: idelalisib + mFOLFOX6), their metabolites, or formulation excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468557


Locations
Layout table for location information
United States, Arizona
Scottsdale Healthcare Clinical Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Indiana
Indiana University Goshen Center for Cancer Care
Goshen, Indiana, United States, 46506
United States, Massachusetts
Dana Farber/ Harvard Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Mario Marcondes, MD, PhD Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02468557     History of Changes
Other Study ID Numbers: GS-US-385-1577
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by Gilead Sciences:
Relapsed/refractory pancreatic ductal adenocarcinoma
Previously untreated pancreatic ductal adenocarcinoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Idelalisib
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors