Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
Conditions
Advanced Solid Malignancy - Safety and Tolerability - Pharmacokinetics - Pharmacodynamics - Tumour Response - Advanced or Metastatic Breast Cancer - Ovarian Cancer - Cervical Cancer - Endometrial Cancer - PIK3CA - AKT1 - ER+ - HER2+
Conditions: official terms
Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
Advanced solid malignancy,refractory,PIK3CA mutated,AKT1 mutated, metastatic,ER+ HER2+,breast,ovarian,endometrial,AZD5363
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: AZD5363 Type: Drug
Name: AZD5363 Type: Drug
Name: AZD5363 Type: Drug
Overall Status
Recruiting
Summary
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 or PIK3CA mutation.
Detailed Description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Aged at least 18 years.

- Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.

- ER+/HER2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a PIK3CA gene mutation (Part C), AKT1 gene mutation (Part D) or a dysregulatory aberration on the PIK/AKT pathway (Part D)

- The presence of at least one lesion that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. Estimated life expectancy of more than 12 weeks.

- Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

- Clinically significant abnormalities of glucose metabolism.

- Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).

- Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

- Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures.

- A bad reaction to AZD5363 or any drugs similar to it in structure or class.
Locations
Research Site
Los Angeles, California, United States
Status: Recruiting
Research Site
Stanford, California, United States
Status: Recruiting
Research Site
Aurora, Colorado, United States
Status: Recruiting
Research Site
New Haven, Connecticut, United States
Status: Not yet recruiting
Research Site
Boston, Massachusetts, United States
Status: Recruiting
Research Site
New York, New York, United States
Status: Recruiting
Research Site
Oklahoma City, Oklahoma, United States
Status: Recruiting
Research Site
Portland, Oregon, United States
Status: Recruiting
Research Site
Charleston, South Carolina, United States
Status: Recruiting
Research Site
Nashville, Tennessee, United States
Status: Recruiting
Research Site
Houston, Texas, United States
Status: Recruiting
Research Site
Edmonton, Alberta, Canada
Status: Not yet recruiting
Research Site
Vancouver, British Columbia, Canada
Status: Recruiting
Research Site
Toronto, Ontario, Canada
Status: Recruiting
Research Site
Montreal, Quebec, Canada
Status: Recruiting
Research Site
Paris Cedex 5, France
Status: Recruiting
Research Site
Pierre Benite Cedex, France
Status: Recruiting
Research Site
Erlangen, Germany
Status: Withdrawn
Research Site
Frankfurt, Germany
Status: Withdrawn
Research Site
Heidelberg, Germany
Status: Withdrawn
Research Site
Milano, Italy
Status: Recruiting
Research Site
Napoli, Italy
Status: Recruiting
Research Site
Prato, Italy
Status: Recruiting
Research Site
Chuo-ku, Japan
Status: Recruiting
Research Site
Kashiwa-shi, Japan
Status: Recruiting
Research Site
Koto-ku, Japan
Status: Not yet recruiting
Research Site
Amsterdam, Netherlands
Status: Recruiting
Research Site
Madrid, Spain
Status: Recruiting
Research Site
Valencia, Spain
Status: Recruiting
Research Site
Singapore, United Kingdom
Status: Recruiting
Start Date
December 2010
Completion Date
October 2016
Sponsors
AstraZeneca
Source
AstraZeneca
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page