Trials / Active Not Recruiting
Active Not RecruitingNCT04644068
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 702 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
Summary
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Detailed description
This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.
Conditions
- Ovarian Cancer
- Breast Cancer
- Pancreatic Cancer
- Prostate Cancer
- Additional Indications Below for Module 4 and 5
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Bladder Cancer
- Gastric Cancer
- Biliary Cancer
- Cervical Cancer
- Endometrial Cancer
- Small Cell Lung Cancer Only in Module 5
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD5305 | Oral PARP inhibitor |
| DRUG | Paclitaxel | IV Anti-microtubule agent |
| DRUG | Carboplatin | IV Platinum chemotherapeutic |
| DRUG | T- Dxd | IV Antibody-drug conjugate |
| DRUG | Dato-DXd | IV Antibody-drug conjugate |
| DRUG | Camizestrant | Oral SERD Molecule |
Timeline
- Start date
- 2020-11-12
- Primary completion
- 2027-05-28
- Completion
- 2027-05-28
- First posted
- 2020-11-25
- Last updated
- 2026-02-19
Locations
68 sites across 14 countries: United States, Australia, Canada, China, Czechia, Hungary, Italy, Japan, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04644068. Inclusion in this directory is not an endorsement.