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NCT03989115 · ClinicalTrials.gov registry record · Phase 1
Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
A Phase 1 study, sponsored by Revolution Medicines.
- Completed
- Registry status
- Phase 1
- Development phase
- 113
- Enrollment target
NCT03989115: Completed Phase 1 study, sponsored by Revolution Medicines.
NCT03989115 is a Phase 1 study that has completed, run by Revolution Medicines. The registered enrollment target is 113 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03989115, a Phase 1 study, has completed, sponsored by Revolution Medicines.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 113 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific genomic aberrations and to identify the recommended Phase 2 dose (RP2D); and to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a participant, temporally associated with the use of a pharmaceutical / an investigational product, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered relate
Interventions
- DRUG Cobimetinib
- DRUG RMC-4630
- DRUG Drug: Osimertinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2019-07-02 |
| Est. Completion | 2022-02-08 |
| Phase | Phase 1 |
What the finished NCT03989115 record still lists
NCT03989115 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 3 interventions - of which Cobimetinib is the first listed.
NCT03989115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03989115 about?
NCT03989115 is a clinical study titled "Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific genomic aberrations and to identify the recommended Phase 2 dose (RP2D); and...
What is the current status of trial NCT03989115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 113 participants. The study started on 2019-07-02. Estimated completion is 2022-02-08.
What interventions are being tested in trial NCT03989115?
The interventions under investigation include: Cobimetinib (DRUG), RMC-4630 (DRUG), Drug: Osimertinib (DRUG).
Who is sponsoring clinical trial NCT03989115?
This trial is sponsored by Revolution Medicines, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03989115's enrollment target sits among peer trials
113 508th of 2000 higher than 1,493 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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