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NCT01552434 · ClinicalTrials.gov registry record · Phase 1
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
A Phase 1 study of Malignant Neoplasm and Malignant Female Reproductive System Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 155
- Enrollment target
- 1
- Study location
NCT01552434: Active Phase 1 study of Malignant Neoplasm and Malignant Female Reproductive System Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT01552434 is a Phase 1 study of Malignant Neoplasm and Malignant Female Reproductive System Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 155 participants, below the 511-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01552434, a Phase 1 study of Malignant Neoplasm and Malignant Female Reproductive System Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 155 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Immunotherapy with bevacizumab and cetuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bevacizumab and temsirolimus work better when given alone or with valproic acid or cetuximab in treating patients with a malignancy or other disease that is not cancerous.
Primary Outcome
Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Bevacizumab
- DRUG Temsirolimus
- OTHER Pharmacological Study
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2012-03-16 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT01552434 still lists
NCT01552434 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 511-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (70% lower).
The record links to 10 conditions, with Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cetuximab is the first listed.
NCT01552434 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01552434 about?
NCT01552434 is a clinical study titled "Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease". This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Immunotherapy with bevacizumab ...
What is the current status of trial NCT01552434?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2012-03-16. Estimated completion is 2026-03-31.
What conditions does trial NCT01552434 study?
This clinical trial studies the following conditions: Malignant Neoplasm, Malignant Female Reproductive System Neoplasm, Advanced Malignant Neoplasm, Lymphangioleiomyomatosis, Erdheim-Chester Disease.
What interventions are being tested in trial NCT01552434?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Temsirolimus (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01552434?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01552434 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Neoplasm
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 NCT01552434's enrollment target sits among peer trials
155 25th of 59 higher than 35 of 59 other Malignant Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Neoplasm 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.
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