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NCT06308419 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
A Phase 1 study of Leiomyosarcoma and Soft Tissue Sarcomas, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06308419: Recruiting Phase 1 study of Leiomyosarcoma and Soft Tissue Sarcomas, sponsored by M.D. Anderson Cancer Center.
NCT06308419 is a Phase 1 study of Leiomyosarcoma and Soft Tissue Sarcomas that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 121-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06308419, a Phase 1 study of Leiomyosarcoma and Soft Tissue Sarcomas, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Nab-Sirolimus
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2031-02-01 |
| Phase | Phase 1 |
What NCT06308419 shows while recruiting
NCT06308419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 121-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Leiomyosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT06308419 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06308419 about?
NCT06308419 is a clinical study titled "A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions". To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas.
What is the current status of trial NCT06308419?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-08-14. Estimated completion is 2031-02-01.
What conditions does trial NCT06308419 study?
This clinical trial studies the following conditions: Leiomyosarcoma, Soft Tissue Sarcomas.
What interventions are being tested in trial NCT06308419?
The interventions under investigation include: Gemcitabine (DRUG), Nab-Sirolimus (DRUG).
Who is sponsoring clinical trial NCT06308419?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06308419 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 Leiomyosarcoma
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 NCT06308419's enrollment target sits among peer trials
18 15th of 16 higher than 2 of 16 other Leiomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyosarcoma 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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