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NCT02201212 · ClinicalTrials.gov registry record · Phase 2
Everolimus for Cancer With TSC1 or TSC2 Mutation
A Phase 2 study of Tuberous Sclerosis Complex and TSC1, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT02201212: Completed Phase 2 study of Tuberous Sclerosis Complex and TSC1, sponsored by Dana-Farber Cancer Institute.
NCT02201212 is a Phase 2 study of Tuberous Sclerosis Complex and TSC1 that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 30 participants, below the 154-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201212, a Phase 2 study of Tuberous Sclerosis Complex and TSC1, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
In this research study, the investigators are evaluating the clinical benefit of everolimus in cancer patients with inactivating TSC1 or TSC2 mutations or activating MTOR mutations. This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug called everolimus to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved everolimus for your type of cancer. Everolimus is a drug that may stop cancer cells from growing by blocking an important factor (mTOR) involved in the growth of cells. This drug has been used in treatment for other cancers and is approved by the Food and Drug Administration for treatment of several types of cancer, including renal cell carcinoma. Treatment with this drug has been associated with responses in some patients whose cancers had mutations in TSC1 or TSC2. The investigators think that patients whose tumors have mutations in TSC1 or TSC2 may have a good chance of responding to treatment with drugs like everolimus.
Primary Outcome
RECIST 1.1 criteria for Objective Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Conditions Studied
Interventions
- DRUG Everolimus
Study Locations (2)
Massachusetts
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-09 |
| Est. Completion | 2019-06 |
| Phase | Phase 2 |
What the finished NCT02201212 record still lists
NCT02201212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 154-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (81% lower).
The record links to 4 conditions, with Tuberous Sclerosis Complex appearing as the primary indexed condition, and to 1 intervention - of which Everolimus is the first listed.
NCT02201212 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT02201212 about?
NCT02201212 is a clinical study titled "Everolimus for Cancer With TSC1 or TSC2 Mutation". In this research study, the investigators are evaluating the clinical benefit of everolimus in cancer patients with inactivating TSC1 or TSC2 mutations or activating MTOR mutations. This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug...
What is the current status of trial NCT02201212?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2014-09. Estimated completion is 2019-06.
What conditions does trial NCT02201212 study?
This clinical trial studies the following conditions: Tuberous Sclerosis Complex, TSC1, TSC2, MTOR.
What interventions are being tested in trial NCT02201212?
The interventions under investigation include: Everolimus (DRUG).
Who is sponsoring clinical trial NCT02201212?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02201212 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tuberous Sclerosis Complex
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02201212's enrollment target sits among peer trials
30 7th of 8 higher than 2 of 8 other Tuberous Sclerosis Complex trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberous Sclerosis Complex 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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