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NCT01802632 · ClinicalTrials.gov registry record · Phase 1
AZD9291 First Time In Patients Ascending Dose Study
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 603
- Enrollment target
NCT01802632: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01802632 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 603 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (905% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802632, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 603 participants
- Enrollment target
Study Summary
This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.
Primary Outcome
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer
Interventions
- DRUG AZD9291
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 603 participants |
| Start Date | 2013-03-04 |
| Est. Completion | 2023-12-11 |
| Phase | Phase 1 |
What the finished NCT01802632 record still lists
NCT01802632 is an interventional study that assigns participants to a tested intervention. The registered 603 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 (905% higher).
The record links to 0 conditions, and to 1 intervention - of which AZD9291 is the first listed.
NCT01802632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01802632 about?
NCT01802632 is a clinical study titled "AZD9291 First Time In Patients Ascending Dose Study". This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what...
What is the current status of trial NCT01802632?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 603 participants. The study started on 2013-03-04. Estimated completion is 2023-12-11.
What interventions are being tested in trial NCT01802632?
The interventions under investigation include: AZD9291 (DRUG).
Who is sponsoring clinical trial NCT01802632?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01802632's enrollment target sits among peer trials
603 27th of 2000 higher than 1,974 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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