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NCT02610075 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study to Determine MTD of AZD1775 Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumours.
A Phase 1 study of Ovarian Cancer and Locally Advanced Solid Tumours, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 3
- Study locations
NCT02610075: Completed Phase 1 study of Ovarian Cancer and Locally Advanced Solid Tumours, sponsored by AstraZeneca.
NCT02610075 is a Phase 1 study of Ovarian Cancer and Locally Advanced Solid Tumours that has completed, run by AstraZeneca. The registered enrollment target is 62 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02610075, a Phase 1 study of Ovarian Cancer and Locally Advanced Solid Tumours, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 3
- Study locations
Study Summary
This Phase Ib study will identify the Maximum Tolerated Dose (MTD) of AZD1775 monotherapy when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2 days rest) in 21-day cycles in patients with locally advanced or metastatic solid tumours. Alternative treatment schedules may be explored if preliminary data suggest these would be more appropriate. The effect of food on single dose PK of AZD1775 will be assessed in 12 patients. In this sub-study, patients will receive a single oral dose of AZD1775 with 240 mL of water, once in the fasted state and once following a high-fat meal.
Primary Outcome
The MTD will be determined through dose-escalation using a 3+3 cohort design. If less than one-third of evaluable patients in a given cohort (0 of 3 patients or 1 of 6 patients) experiences a DLT; escalation may proceed to the next higher dose level. If one of the first 3 patients enrolled in a given cohort experiences a dose-limiting toxicity (DLT), at least 3 additional patents will be enrolled in that cohort. If a DLT is observed in one-third or more of patients, the dose at which this occurs
Conditions Studied
Interventions
- DRUG AZD1775
Study Locations (3)
Arizona
- Research Site - Scottsdale
Colorado
- Research Site - Denver
Tennessee
- Research Site - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-12-01 |
| Est. Completion | 2018-04-26 |
| Phase | Phase 1 |
What the finished NCT02610075 record still lists
NCT02610075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which AZD1775 is the first listed.
NCT02610075 reports a single indexed study location in Arizona, Colorado, Tennessee.
Frequently Asked Questions
What is clinical trial NCT02610075 about?
NCT02610075 is a clinical study titled "Phase Ib Study to Determine MTD of AZD1775 Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumours.". This Phase Ib study will identify the Maximum Tolerated Dose (MTD) of AZD1775 monotherapy when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2 days rest) in 21-day cycl...
What is the current status of trial NCT02610075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2015-12-01. Estimated completion is 2018-04-26.
What conditions does trial NCT02610075 study?
This clinical trial studies the following conditions: Ovarian Cancer, Locally Advanced Solid Tumours, Metastatic Solid Tumours.
What interventions are being tested in trial NCT02610075?
The interventions under investigation include: AZD1775 (DRUG).
Who is sponsoring clinical trial NCT02610075?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02610075 being conducted?
This trial has 3 study locations across Arizona, Colorado, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02610075's enrollment target sits among peer trials
62 191st of 322 higher than 132 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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.
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