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Brief Title: 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

INTRODUCTION

  • Org Study ID: D9720C00001
  • Secondary ID: N/A
  • NTC ID: NCT04644068
  • Sponsor: AstraZeneca
BreastCancerStudyLocator.com

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    November 12, 2020
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: The number of subjects with adverse events/serious adverse events

Primary Outcome 1 - Timeframe: From time of Informed Consent to 28 days post last dose (approximately 1 year). 40 days post last dose for Module 4

Primary Outcome 2 - Measure: The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.

Primary Outcome 2 - Timeframe: From first dose of study treatment until the end of Cycle 1.

CONDITION

  • Ovarian Cancer
  • Breast Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Additional Indications Below for Module 4 and 5
  • Non-small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Colorectal Cancer
  • Bladder Cancer
  • Gastric Cancer
  • Biliary Cancer
  • Cervical Cancer
  • Endometrial Cancer

ELIGIBILITY

Key Inclusion Criteria:
Age ≥ 18 at the time of screening

- Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..

- Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)

- Life expectancy ≥ 12 weeks

- Progressive cancer at the time of study entry

- Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B

- Adequate organ and marrow function as defined by the protocol.

- For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
For Part A:
- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)
For Part B:
- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).
Key Exclusion Criteria:
Treatment with any of the following:
Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment

- Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment

- Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment

- Any live virus or bacterial vaccine within 28 days of the first dose of study treatment

- Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong and moderate inhibitors or inducers.

- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.

- Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.

- Major surgery within 4 weeks of the first dose of study treatment.

- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.

- Any history of persisting (> 2 weeks) severe pancytopenia due to any cause

- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.

- Cardiac conditions as defined by the clinical study protocol
Other cardiovascular diseases as defined by any of the following:
Symptomatic heart failure,

- uncontrolled hypertension,

- hypertensive heart disease with significant left ventricular hypertrophy

- acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.

- cardiomyopathy of any etiology

- presence of clinically significant valvular heart disease

- history of atrial or ventricular arrhythmia requiring treatment.

- subjects with atrial fibrillation and optimally controlled ventricular rate are permitted

- transient ischaemic attack, or stroke within 6 months prior to screening

- patients with symptomatic hypotension at screening

- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305

- Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
other module-specific criteria may apply

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Timothy Yap

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: Timothy Yap

Phone: 1-877-240-9479, +1-877-400-4656

Email: information.center@astrazeneca.com, AstraZeneca@CareboxHealth.com

LOCATION

Facility Status Contact
Facility: Research Site
New York, New York 10021
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Melbourne, British Columbia 3000
Australia
Status: Recruiting Contact: N/A
Facility: Research Site
Brno, 656 53
Czechia
Status: Recruiting Contact: N/A
Facility: Research Site
Budapest, 1062
Hungary
Status: Recruiting Contact: N/A
Facility: Research Site
Budapest, 1122
Hungary
Status: Recruiting Contact: N/A
Facility: Research Site
Milan, 20141
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Napoli, 80131
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Gdynia, 81-519
Poland
Status: Recruiting Contact: N/A
Facility: Research Site
Warszawa, 02-781
Poland
Status: Recruiting Contact: N/A
Facility: Research Site
Moscow, 111123
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Moscow, 115478
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Moscow, 117997
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Madrid, 28050
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Sevilla, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Cambridge, CB2 0QQ
United Kingdom
Status: Recruiting Contact: N/A
Facility: Research Site
Manchester, M20 4BX
United Kingdom
Status: Recruiting Contact: N/A
Facility: Research Site
Sutton, SM2 5PT
United Kingdom
Status: Recruiting Contact: N/A