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NCT01577745 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01577745: Completed Phase 1 study, sponsored by MedImmune.
NCT01577745 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01577745, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI0639.
Primary Outcome
The MTD evaluation was based on the dose-limiting toxicity (DLT) evaluable population. DLT is defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT evaluation period (defined as the time from the first dose of MEDI0639 to 21 days after the first dose), except for National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hypertension that could be controlled within 96 hours; Grade 3 symptomatic hypertension of greater than (\>) 180
Interventions
- BIOLOGICAL MEDI0639
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01577745 record still lists
NCT01577745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which MEDI0639 is the first listed.
NCT01577745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01577745 about?
NCT01577745 is a clinical study titled "A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors". This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI0639.
What is the current status of trial NCT01577745?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2012-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01577745?
The interventions under investigation include: MEDI0639 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01577745?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01577745's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 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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