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.
18 Years
N/A
Both
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+
Trial Information
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.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Parts A,B,C,D: Safety and tolerability of AZD5363 in terms of adverse events and serious adverse events
Outcome Time Frame:
Adverse events, serious adverse events and deaths will be collected from screening to 28 days after study drug discontinuation.
Safety Issue:
Yes
Principal Investigator
Paul Stockman, MBChB, PhD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
D3610C00001
NCT ID:
NCT01226316
Start Date:
November 2010
Completion Date:
December 2016
Related Keywords:
- 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+
- Advanced solid malignancy,refractory,PIK3CA mutated,AKT1 mutated, metastatic,ER+ HER2+,breast,ovarian,endometrial,AZD5363
- Breast Neoplasms
- Neoplasms
- Endometrial Neoplasms
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Adenoma
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