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NCT00699491 · ClinicalTrials.gov registry record · Phase 1
Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00699491: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00699491 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00699491, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.
Primary Outcome
The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported. Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temsirolimus
- OTHER Pharmacological Study
- BIOLOGICAL Cixutumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2008-10-31 |
| Est. Completion | 2018-02-14 |
| Phase | Phase 1 |
What the finished NCT00699491 record still lists
NCT00699491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00699491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00699491 about?
NCT00699491 is a clinical study titled "Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer". This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other p...
What is the current status of trial NCT00699491?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2008-10-31. Estimated completion is 2018-02-14.
What interventions are being tested in trial NCT00699491?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temsirolimus (DRUG), Pharmacological Study (OTHER), Cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00699491?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00699491's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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