Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma
NCT ID: NCT02468557
Last Updated: 2021-04-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
16 participants
INTERVENTIONAL
2015-07-30
2016-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Decitabine and Gemcitabine for Pancreatic Cancer and Sarcoma
NCT02959164
Adebrelimab and Chidamide for Pancreatic Cancer
NCT06584227
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
NCT02101021
Second Line Treatment With Nal-IRI and S1 in Pancreatic Cancer
NCT03986294
Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas
NCT00837031
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Idelalisib 150 mg
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
Idelalisib
Tablets administered orally twice daily
Idelalisib + nab-paclitaxel
Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + nab-paclitaxel.
Idelalisib
Tablets administered orally twice daily
Nab-paclitaxel
125 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle
Idelalisib + mFOLFOX6
Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + mFOLFOX6.
Idelalisib
Tablets administered orally twice daily
mFOLFOX6
mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 milligram/meter per square (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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Idelalisib
Tablets administered orally twice daily
Nab-paclitaxel
125 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle
mFOLFOX6
mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 milligram/meter per square (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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
* Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin
* Measurable disease per response evaluation criteria in solid tumors (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) serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamic pyruvic transaminase (SGPT) \< 2.5 x ULN, and albumin \> 3.0 g/dL
* Hematological: absolute neutrophil count (ANC) \> 1,500 cells/cubic millimetre (m\^3), platelet \> 100,000 cells/mm\^3, hemoglobin \> 9.0 grams/decilitre (g/dL)
* Renal: Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance (CrCl) \> 30 millilitre (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 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 human immunodeficiency viruses (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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scottsdale Healthcare Clinical Research Institute
Scottsdale, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Indiana University Goshen Center for Cancer Care
Goshen, Indiana, United States
Dana Farber/ Harvard Cancer Institute
Boston, Massachusetts, United States
University of Rochester
Rochester, New York, United States
Greenville Hospital System
Greenville, South Carolina, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Borazanci E, Pishvaian MJ, Nemunaitis J, Weekes C, Huang J, Rajakumaraswamy N. A Phase Ib Study of Single-Agent Idelalisib Followed by Idelalisib in Combination with Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma. Oncologist. 2020 Nov;25(11):e1604-e1613. doi: 10.1634/theoncologist.2020-0321. Epub 2020 Jun 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GS-US-385-1577
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.