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NCT03840200 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT03840200: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03840200 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03840200, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer and a Dose-Expansion Phase (Part 2) in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide).
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investig
Interventions
- DRUG Ipatasertib
- DRUG Rucaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2022-01-04 |
| Phase | Phase 1 |
What the finished NCT03840200 record still lists
NCT03840200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Ipatasertib is the first listed.
NCT03840200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03840200 about?
NCT03840200 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.". This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previousl...
What is the current status of trial NCT03840200?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2019-06-12. Estimated completion is 2022-01-04.
What interventions are being tested in trial NCT03840200?
The interventions under investigation include: Ipatasertib (DRUG), Rucaparib (DRUG).
Who is sponsoring clinical trial NCT03840200?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03840200's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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