Metastatic Pancreatic Adenocarcinoma | A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic Cancer
Metastatic Pancreatic Adenocarcinoma research study
What is the primary objective of this study?
This is a phase 1b, multi-center, open label, randomized study to evaluate the safety and feasibility of administering metformin with or without rapamycin after disease stabilization on chemotherapy in subjects with metastatic PDA.
Who is eligible to participate?
Inclusion Criteria: - Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma. Subjects with islet cell neoplasms are excluded. - Have received 6 months of chemotherapy. - Have stable disease for at least 6 months on the current regimen with the last 2 scans taken at least 6 months apart. Measurable disease not required. - Eastern Cooperative Oncology Group performance status 0 or 1. - Life expectancy of greater than 12 weeks. - Adequate organ and marrow function. - Oxygen saturation on room air > 92 % by pulse oximetry. (Subjects on intermittent or continuous supplemental oxygen are excluded). - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Receiving or has received any other investigational agents within 28 days prior to Day 1 of treatment in this study. - Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to Day 1 of treatment in this study. - Known history of brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids). - History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or rapamycin. - Taking ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin, rifampin, rifabutin, bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine, troleandomycin, verapamil, carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort (Hypericum perforatum), and grapefruit juice. Subjects on metformin will not be excluded. - Has received any non-oncology live vaccine therapy used for prevention of infectious diseases for up to 28 days prior to or after the initiation of treatment in this study. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, viral, or fungal infection(s) requiring systemic therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the subject to receive an experimental research drug. - Unhealed surgical wound or other clinically significant wound. - Known history of chronic HIV, Hepatitis B or hepatitis C infections. - Pregnant or breast feeding. - Unwilling or unable to comply with study procedures. - Cannot reliably swallow pills.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Metastatic Pancreatic Adenocarcinoma
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:metformin alone (Arm A)metformin alone
Drug:metformin (Arm B)rapamycin + metformin
Drug:rapamycin (Arm B)rapamycin + metformin
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
A - metformin alonemetformin alone Arm A patients will receive metformin 850mg orally twice a day on a 28 day cycle.
B - metformin + rapamycinmetformin + rapamycin Arm B patients will receive 850mg orally twice a day and rapamycin 4mg orally once a day on a 28 day cycle.
Active, not recruiting
Start Date: January 2014
Completed Date: June 2019
Phase: Phase 1/Phase 2
Primary Outcome: safety and feasibility
Study sponsors, principal investigator, and references
Principal Investigator: Dung Le, MD
Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins