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NCT01794520 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
NCT01794520 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 117 participants.
The verdict
NCT01794520, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
Study Summary
The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma. The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.
Interventions
- DRUG Venetoclax
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2012-10-10 |
| Est. Completion | 2021-11-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01794520
The ClinicalTrials.gov registry entry for NCT01794520 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT01794520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01794520 about?
NCT01794520 is a clinical study titled "Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma". The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractor...
What is the current status of trial NCT01794520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2012-10-10. Estimated completion is 2021-11-29.
What interventions are being tested in trial NCT01794520?
The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01794520?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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