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NCT03430882 · ClinicalTrials.gov registry record · Phase 1
Sapanisertib, Carboplatin, and Paclitaxel in Treating Patients With Recurrent or Refractory Malignant Solid Tumors
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT03430882: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03430882 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03430882, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This phase I trial studies the sides effects and best dose of sapanisertib, carboplatin, and paclitaxel in treating patients with malignant solid tumors that have come back (recurrent) or do not respond to treatment (refractory). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing cells, by stopping them from dividing, or by stopping them from spreading. Giving sapanisertib, carboplatin, and paclitaxel may work better in treating patients with malignant solid tumors.
Primary Outcome
Wilcoxon's Signed-Rank Test and Fisher's exact test will be used for data analysis of continuous variables and categorical variables, respectively. A mixed model accounting for patient effects will be used to analyze longitudinal data over time. Descriptive statistics will be provided on the grade and type of toxicity by dose level.
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Sapanisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-03-12 |
| Est. Completion | 2022-06-08 |
| Phase | Phase 1 |
What the finished NCT03430882 record still lists
NCT03430882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT03430882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03430882 about?
NCT03430882 is a clinical study titled "Sapanisertib, Carboplatin, and Paclitaxel in Treating Patients With Recurrent or Refractory Malignant Solid Tumors". This phase I trial studies the sides effects and best dose of sapanisertib, carboplatin, and paclitaxel in treating patients with malignant solid tumors that have come back (recurrent) or do not respond to treatment (refractory). Sapanisertib may stop the growth of tumor cells by blocking some of th...
What is the current status of trial NCT03430882?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2018-03-12. Estimated completion is 2022-06-08.
What interventions are being tested in trial NCT03430882?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Sapanisertib (DRUG).
Who is sponsoring clinical trial NCT03430882?
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 NCT03430882's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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