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NCT04085315 · ClinicalTrials.gov registry record · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
A Phase 1 study of EGFR Gene Mutation and Lung Cancer Metastatic, sponsored by Collin Blakely.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04085315: Recruiting Phase 1 study of EGFR Gene Mutation and Lung Cancer Metastatic, sponsored by Collin Blakely.
NCT04085315 is a Phase 1 study of EGFR Gene Mutation and Lung Cancer Metastatic that is actively recruiting participants, run by Collin Blakely. The registered enrollment target is 38 participants, below the 218-participant average among 9 other EGFR Gene Mutation trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04085315, a Phase 1 study of EGFR Gene Mutation and Lung Cancer Metastatic, is actively recruiting participants, sponsored by Collin Blakely.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be important for the growth of lung cancer. Osimertinib may reduce tumor growth by blocking the action of a certain mutant protein (EGFR). This study may help researchers test the safety of alisertib at different dose levels in combination with osimertinib, and to find out what effects, good and/or bad, it has on EGFR-mutated lung cancer.
Primary Outcome
The MTD is the highest dose at which no more than one instance of a dose-limiting toxicity is observed among the 6 participants treated.
Conditions Studied
Interventions
- DRUG Osimertinib
- DRUG Alisertib
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-11-12 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT04085315 shows while recruiting
NCT04085315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 218-participant average among 9 other EGFR Gene Mutation trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with EGFR Gene Mutation appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.
NCT04085315 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04085315 about?
NCT04085315 is a clinical study titled "Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer". This phase I/Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be im...
What is the current status of trial NCT04085315?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2019-11-12. Estimated completion is 2026-12-31.
What conditions does trial NCT04085315 study?
This clinical trial studies the following conditions: EGFR Gene Mutation, Lung Cancer Metastatic.
What interventions are being tested in trial NCT04085315?
The interventions under investigation include: Osimertinib (DRUG), Alisertib (DRUG).
Who is sponsoring clinical trial NCT04085315?
This trial is sponsored by Collin Blakely, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04085315 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04085315's enrollment target sits among peer trials
38 7th of 9 higher than 3 of 9 other EGFR Gene Mutation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other EGFR Gene Mutation 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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