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NCT03770689 · ClinicalTrials.gov registry record · Phase 1
Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03770689: Completed Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT03770689 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03770689, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).
Primary Outcome
DLT is defined as any of following treatment emergent adverse events (TEAEs) considered possibly related to study treatment by Investigator and/or Sponsor up to completion of assigned chemoradiotherapy treatment. DLT were based on SMC: Adverse drug reaction that, in the opinion of SMC, is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any occurrence of drug-induced liver injury meeting the Hy's law criteria; Any Grade 3 toxici
Interventions
- DRUG Capecitabine
- DRUG Peposertib 50 mg
- DRUG Peposertib 100 mg
- DRUG Peposertib 150 mg
- DRUG Peposertib 250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2022-02-21 |
| Phase | Phase 1 |
What the finished NCT03770689 record still lists
NCT03770689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT03770689 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03770689 about?
NCT03770689 is a clinical study titled "Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer". The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).
What is the current status of trial NCT03770689?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-03-20. Estimated completion is 2022-02-21.
What interventions are being tested in trial NCT03770689?
The interventions under investigation include: Capecitabine (DRUG), Peposertib 50 mg (DRUG), Peposertib 100 mg (DRUG), Peposertib 150 mg (DRUG), Peposertib 250 mg (DRUG).
Who is sponsoring clinical trial NCT03770689?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03770689's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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