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NCT02740985 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 313
- Enrollment target
NCT02740985: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02740985 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 313 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (422% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02740985, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 313 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, multicenter study of continuous oral dosing of AZD4635 administered to patients with advanced solid malignancies. Dosing will be escalated until a maximum-tolerated dose (MTD) is determined in patients. The MTD will be defined by dose-limiting toxicity. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of the patients. Expansion cohorts will further assess safety and preliminary anti-tumor activity in a variety of advanced solid tumor malignancies. Other dosing schedules and/or combinations may be evaluated based on the emerging PK and safety data. The primary objectives of this study are to: * Investigate the safety and tolerability of AZD4635 monotherapy when given orally (PO) to patients with advanced solid malignancies. * Investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4635 monotherapy capsule formulation when given to patients with advanced solid malignancies. * Investigate the safety and tolerability of AZD4635 PO when given in combination with durvalumab, durvalumab plus oleclumab, or docetaxel to patients with advanced solid malignancies and to investigate the safety and tolerability of AZD4635 in combination with abiraterone acetate or enzalutamide in patients with mCRPC. * Define the maximum-tolerated dose (MTD) of AZD4635 in combination with durvalumab. * Define the recommended Phase 2 dose (RP2D) of AZD4635 in combination with abiraterone acetate or enzalutamide. * Determine the safety, tolerability, and immune effects of AZD4635 when administered in combination with durvalumab to patients with non-small cell lung cancer (NSCLC) who have previously received immunotherapy (Phase 1b portion). * Investigate the safety and tolerability of AZD4635 capsule formulation in combination with durvalumab and oleclumab when given to patients with mCRPC or advanced solid tumor malignancy. * Define the RP2D of AZD4635 capsule formulation in combination with durvalum
Primary Outcome
A Bayesian Logistic Regression Model (BLRM) based approach will be used to identify the set of AZD4635 doses where the incidence of DLTs is no larger than 33%. In each arm, up to 3 patients will be initially assessed. The dose will be escalated to the next higher dose level if all 3 patients in the previous dose level complete the DLT evaluation period without a DLT. Following the first DLT, the BLRM model will be run and the output made available to the safety review committee (SRC) to guide fu
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone Acetate
- DRUG Durvalumab
- DRUG Oleclumab
- DRUG AZD4635
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2016-06-17 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
What the finished NCT02740985 record still lists
NCT02740985 is an interventional study that assigns participants to a tested intervention. The registered 313 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 (422% higher).
The record links to 0 conditions, and to 5 interventions - of which Enzalutamide is the first listed.
NCT02740985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02740985 about?
NCT02740985 is a clinical study titled "A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies". This is a Phase 1, open-label, multicenter study of continuous oral dosing of AZD4635 administered to patients with advanced solid malignancies. Dosing will be escalated until a maximum-tolerated dose (MTD) is determined in patients. The MTD will be defined by dose-limiting toxicity. The study desig...
What is the current status of trial NCT02740985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 313 participants. The study started on 2016-06-17. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT02740985?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone Acetate (DRUG), Durvalumab (DRUG), Oleclumab (DRUG), AZD4635 (DRUG).
Who is sponsoring clinical trial NCT02740985?
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 NCT02740985's enrollment target sits among peer trials
313 118th of 2000 higher than 1,882 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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