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NCT02145559 · ClinicalTrials.gov registry record · Phase 1
A Pharmacodynamic Study of Sirolimus and Metformin in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02145559 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 24 participants.
The verdict
NCT02145559, a Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Given the role of mTOR signaling and probable synergistic activity of combining sirolimus and metformin in patients with advanced solid tumors, the investigators hypothesize that: 1. The combination of metformin plus sirolimus will result in reduction of p4EBP1, p70S6K and pAKT more than sirolimus alone in peripheral blood T cells (PBTC). 2. The combination of metformin plus sirolimus will result in decreased levels of serum biomarkers including fasting insulin, C-peptide, glucose, triglycerides, LDH, IGF-1, IGF-1R, IGF-BP and leptin, but an increase in adiponectin in peripheral blood. 3. Expression of active forms of AMPK, mTOR, PI3K, PTEN loss, AKT, LKB1, P62, LC3, and/or ULK1 in the tumor tissue (original pathology) will be predictive of response to combination therapy. This will be an exploratory hypothesis for this study. 4. Sirolimus induced toxicity, especially hyperglycemia and hypertriglyceridemia, will be mitigated by combining sirolimus with metformin. 5. Metformin plus sirolimus will have promising anti-cancer activity and this activity will correlate with decreases in the above biomarkers. This will be an exploratory hypothesis for this study.
Interventions
- DRUG Sirolimus
- DRUG Metformin XR
- DRUG Delayed Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-04 |
| Est. Completion | 2018-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02145559
The ClinicalTrials.gov registry entry for NCT02145559 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT02145559 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02145559 about?
NCT02145559 is a clinical study titled "A Pharmacodynamic Study of Sirolimus and Metformin in Patients With Advanced Solid Tumors". Given the role of mTOR signaling and probable synergistic activity of combining sirolimus and metformin in patients with advanced solid tumors, the investigators hypothesize that: 1. The combination of metformin plus sirolimus will result in reduction of p4EBP1, p70S6K and pAKT more than sirolimus ...
What is the current status of trial NCT02145559?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-04. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02145559?
The interventions under investigation include: Sirolimus (DRUG), Metformin XR (DRUG), Delayed Metformin (DRUG).
Who is sponsoring clinical trial NCT02145559?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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