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NCT03082209 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT03082209: Completed Phase 1 study, sponsored by AbbVie.
NCT03082209 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03082209, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies. Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.
Primary Outcome
The MTD and/or RP2D of ABBV-621 will be determined during the dose escalation phase of the study of ABBV-621
Interventions
- DRUG Venetoclax
- DRUG Bevacizumab
- DRUG FOLFIRI
- DRUG ABBV-621
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2022-01-21 |
| Phase | Phase 1 |
What the finished NCT03082209 record still lists
NCT03082209 is an interventional study that assigns participants to a tested intervention. The registered 153 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 (155% higher).
The record links to 0 conditions, and to 4 interventions - of which Venetoclax is the first listed.
NCT03082209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03082209 about?
NCT03082209 is a clinical study titled "A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies". This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignanc...
What is the current status of trial NCT03082209?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2017-03-20. Estimated completion is 2022-01-21.
What interventions are being tested in trial NCT03082209?
The interventions under investigation include: Venetoclax (DRUG), Bevacizumab (DRUG), FOLFIRI (DRUG), ABBV-621 (DRUG).
Who is sponsoring clinical trial NCT03082209?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03082209's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 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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