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NCT03101839 · ClinicalTrials.gov registry record · Phase 1
Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid Tumours
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT03101839 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 28 participants.
The verdict
NCT03101839, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
A Phase I, open-label, multicentre, dose-escalation study to investigate the safety, pharmacokinetics and maximum tolerated dose (MTD) of AZD4785 in patients with advanced solid tumours where KRAS may be an important driver of tumour survival. Part A: Dose escalation in patients with solid tumours to evaluate safety, pharmacokinetics and maximum tolerated dose (MTD). Once the maximum tolerated dose (MTD) is established, a dose expansion cohort may be included in Part A, with up to an additional 6 patients to further explore the PK, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 MTD for confirmation of the recommended phase 2 dose (RP2D). Part B: Expansion cohort at the selected dose in patients with non-small cell lung cancer (NSCLC) to evaluate PK parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 RP2D as monotherapy in patients with NSCLC. Approximately 20 patients with NSCLC (Two groups of approximately 10 patients each) with NSCLC will be enrolled to Part B. Group 1 patients will have an option to provide tumour biopsies and Group 2 will be required (mandatory) to provide paired tumour biopsies. Overall up to 12 patients in Group 2Part B patients will be required (mandatory) to may provide paired tumour biopsies. A third group of up to 20 patients with other tumour types and/or a potential different schedule may be added based on the results seen in Parts A and B and any other emerging data and may also provide biopsies.
Interventions
- DRUG AZD4785
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2019-01-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03101839
The ClinicalTrials.gov registry entry for NCT03101839 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AZD4785 is the first listed.
NCT03101839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03101839 about?
NCT03101839 is a clinical study titled "Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid Tumours". A Phase I, open-label, multicentre, dose-escalation study to investigate the safety, pharmacokinetics and maximum tolerated dose (MTD) of AZD4785 in patients with advanced solid tumours where KRAS may be an important driver of tumour survival. Part A: Dose escalation in patients with solid tumours ...
What is the current status of trial NCT03101839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2017-05-15. Estimated completion is 2019-01-08.
What interventions are being tested in trial NCT03101839?
The interventions under investigation include: AZD4785 (DRUG).
Who is sponsoring clinical trial NCT03101839?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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