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NCT01590082 · ClinicalTrials.gov registry record · Phase 1
Doxycycline, Temozolomide and Ipilimumab in Melanoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01590082: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01590082 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01590082, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of doxycycline that can be combined with temozolomide and ipilimumab in patients with advanced melanoma. The safety and level of effectiveness of the study drug combination will also be studied. Doxycycline is designed to treat bacterial infection. It also blocks a protein called iNOS that is important in tumor cell growth, which may slow the growth of or kill cancer cells. Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells. Ipilimumab is designed to block the activity of cells that decrease the immune system's ability to fight cancer.
Primary Outcome
Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Complete Response (CR): Disappearance all target lesions; Any pathological lymph nodes must be \<10mm in short axis. Partial Response (PR): \>30% decrease in sum of diameters of target lesions, reference baseline sum of diameters (e.g. percent change from baseline). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for progressive disease. P
Interventions
- DRUG Ipilimumab
- DRUG Temozolomide
- DRUG Doxycycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
Why NCT01590082 stopped before completion
NCT01590082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Ipilimumab is the first listed.
NCT01590082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01590082 about?
NCT01590082 is a clinical study titled "Doxycycline, Temozolomide and Ipilimumab in Melanoma". The goal of this clinical research study is to find the highest tolerable dose of doxycycline that can be combined with temozolomide and ipilimumab in patients with advanced melanoma. The safety and level of effectiveness of the study drug combination will also be studied. Doxycycline is designed t...
What is the current status of trial NCT01590082?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-11. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01590082?
The interventions under investigation include: Ipilimumab (DRUG), Temozolomide (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT01590082?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01590082's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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