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NCT01537107 · ClinicalTrials.gov registry record · Phase 1
Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01537107: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01537107 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537107, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT will be defined as a course 1 adverse event (Common Terminology Criteria for Adverse Events \[CTCAE\] v 4.0) attributed (definitely, probably, or possibly) to the study treatment. MTD will be examined in an exploratory and hypothesis generating fashion.
Interventions
- OTHER pharmacological study
- PROCEDURE positron emission tomography
- PROCEDURE computed tomography
- DRUG sirolimus
- DRUG vismodegib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-03-05 |
| Est. Completion | 2018-06-27 |
| Phase | Phase 1 |
What the finished NCT01537107 record still lists
NCT01537107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 5 interventions - of which pharmacological study is the first listed.
NCT01537107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01537107 about?
NCT01537107 is a clinical study titled "Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery". This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some ...
What is the current status of trial NCT01537107?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2012-03-05. Estimated completion is 2018-06-27.
What interventions are being tested in trial NCT01537107?
The interventions under investigation include: pharmacological study (OTHER), positron emission tomography (PROCEDURE), computed tomography (PROCEDURE), sirolimus (DRUG), vismodegib (DRUG).
Who is sponsoring clinical trial NCT01537107?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537107's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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