A Study Of Metformin With Or Without Rapamycin As Maintenance Therapy After Induction Chemotherapy In Subjects With Pancreatic Cancer

Study Overview

A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic Cancer

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.

Subjects with metastatic PDA who have received FOLFIRINOX or a gemcitabine-containing regimen and have achieved stable disease or better will be enrolled onto this study. Subjects should have had at least 6 months of chemotherapy and decline continuation of chemotherapy and should have stable disease or better on 2 scans taken at least 6 weeks apart. If applicable, subjects should also have a stable or declining CA19-9. Twenty-two subjects will be randomized in a 1:1 ratio to metformin (Arm A) or metformin + rapamycin (Arm B). Subjects will be stratified according to their prior chemotherapy regimen: FOLFIRINOX or a gemcitabine-containing regimen. Treatments will be administered orally on a 28 day cycle. Metformin will be administered 850mg twice daily and rapamycin will be administered 4mg daily.

Metastatic Pancreatic Adenocarcinoma

DRUG: metformin alone (Arm A)
DRUG: metformin (Arm B)
DRUG: rapamycin (Arm B)

J13146
NA_00090282 (OTHER Identifier) (OTHER: JHMIRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-01-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-04-09
First Submitted that Met QC Criteria 2014-01-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-04-12
First Posted (ACTUAL) 2014-01-29	Results First Posted N/A	Last Verified 2021-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: A - metformin alone metformin alone Arm A patients will receive metformin 850mg orally twice a day on a 28 day cycle.	DRUG: metformin alone (Arm A) metformin alone
ACTIVE_COMPARATOR: B - metformin + rapamycin metformin + rapamycin Arm B patients will receive 850mg orally twice a day and rapamycin 4mg orally once a day on a 28 day cycle.	DRUG: metformin (Arm B) rapamycin + metformin DRUG: rapamycin (Arm B) rapamycin + metformin

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: A - metformin alone

metformin alone Arm A patients will receive metformin 850mg orally twice a day on a 28 day cycle.

DRUG: metformin alone (Arm A)

metformin alone

ACTIVE_COMPARATOR: B - metformin + rapamycin

metformin + rapamycin Arm B patients will receive 850mg orally twice a day and rapamycin 4mg orally once a day on a 28 day cycle.

DRUG: metformin (Arm B)

rapamycin + metformin

DRUG: rapamycin (Arm B)

rapamycin + metformin

Primary Outcome Measures	Measure Description	Time Frame
safety and feasibility	To determine the safety and feasibility of administering metformin with or without rapamycin in subjects with metastatic pancreatic ductal adenocarcinoma (PDA) after disease stabilization on chemotherapy.	1 year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Stand Up To Cancer

Investigators

STUDY_CHAIR: Dung Le, MD, Johns Hopkins SKCCC

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record