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NCT03217266 · ClinicalTrials.gov registry record · Phase 1
Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT03217266: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03217266 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03217266, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This phase Ib trial studies the side effects of navtemadlin and radiation therapy in treating patients with soft tissue sarcoma. Navtemadlin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving navtemadlin and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
Dose was determined separately for each cohort using the classic 3+3 design to determine the safety of each dose level from the number of participants with dose limiting toxicities (DLTs), starting with dose level 1. If dose level 1 were considered unsafe, a lower dose level of twice/week would be tested. The highest dose level deemed safe is considered the MTD. Five additional patients were accrued to the MTD to ensure safety. A DLT is defined as any grade 4-5 adverse event (AE) using the Comm
Interventions
- RADIATION Radiation Therapy
- PROCEDURE Surgical Procedure
- DRUG Navtemadlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2025-09-04 |
| Phase | Phase 1 |
What the finished NCT03217266 record still lists
NCT03217266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT03217266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03217266 about?
NCT03217266 is a clinical study titled "Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma". This phase Ib trial studies the side effects of navtemadlin and radiation therapy in treating patients with soft tissue sarcoma. Navtemadlin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and s...
What is the current status of trial NCT03217266?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2018-06-20. Estimated completion is 2025-09-04.
What interventions are being tested in trial NCT03217266?
The interventions under investigation include: Radiation Therapy (RADIATION), Surgical Procedure (PROCEDURE), Navtemadlin (DRUG).
Who is sponsoring clinical trial NCT03217266?
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 NCT03217266's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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