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NCT04197713 · ClinicalTrials.gov registry record · Phase 1
Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04197713: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT04197713 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04197713, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of adavosertib when given together with olaparib in treating patients with solid tumors that have spread to other places in the body (advanced) with selected mutations. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Giving olaparib and adavosertib one after the other may shrink or stabilize advanced solid tumors as successfully as using them together, with fewer side effects.
Primary Outcome
The number of patients who had dose limiting toxicity (DLT). DLT was defined as grade ≥3 non-hematological toxicity, grade 3 fatigue of greater than 1 week duration, failure to receive at least 70% of dosing due to trial drug-related toxicities, or experiencing a drug-related toxicity that meets criteria for a DLT, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, grade 4 neutropenia ≥5 days or febrile neutropenia, Any degree of anemia, leukopenia in the absence of g
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Adavosertib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What the registry record for NCT04197713 still lists
NCT04197713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.
NCT04197713 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04197713 about?
NCT04197713 is a clinical study titled "Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study". This phase I trial studies the side effects and best dose of adavosertib when given together with olaparib in treating patients with solid tumors that have spread to other places in the body (advanced) with selected mutations. Adavosertib may stop the growth of tumor cells by blocking some of the en...
What is the current status of trial NCT04197713?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-06-30. Estimated completion is 2026-09-30.
What conditions does trial NCT04197713 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.
What interventions are being tested in trial NCT04197713?
The interventions under investigation include: Olaparib (DRUG), Adavosertib (DRUG).
Who is sponsoring clinical trial NCT04197713?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04197713 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
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Where NCT04197713's enrollment target sits among peer trials
13 100th of 108 higher than 8 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid 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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