Status:
COMPLETED
Study of Adavosertib(AZD1775) in Japanese Patients With Advanced Solid Tumours
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Tumours
Eligibility:
All Genders
20-120 years
Phase:
PHASE1
Brief Summary
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics(PK) and anti-tumour activity of adavosertib in Japanese patients with advanced solid tumours. This study consis...
Detailed Description
Objectives: Primary objective: Part A: To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for adavosertib Secondary objective: To determine the PK profile of adavose...
Eligibility Criteria
Inclusion
- Major
- Japanese patients ≥20 years of age at the time of study entry
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0, 1
- Adequate bone marrow reserve or organ function
- Female patients who are not of child-bearing potential, and fertile females of childbearing potential who agree to use adequate contraceptive measures
- Male patients should be willing to use barrier contraception
- Predicted life expectancy ≥12 weeks
- Part A : Histologically or cytologically documented locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable
- Part B : Histologically or cytologically documented locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable and additionally, tumours for which gemcitabine is expected to be effective.
- Measurable or non-measurable disease according to RECIST v1.1
- Major
Exclusion
- Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to Cycle 1 Day 1
- Use of an investigational drug during the past 30 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1
- Common Terminology Criteria for Adverse Events (CTCAE) Grade \>1 toxicity from prior therapy
- Inability to swallow oral medication or any other condition that may impact adavosertib intake/absorption
- Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases
- Any of the cardiac diseases currently or within the last 6 months
- Any underlying medical condition that would impair the patient's ability to receive study treatment
- Other invasive malignancy within 5 years prior to Cycle 1 Day 1 except for non-invasive malignancies
- Part B : Presence of apparent radiological findings for interstitial pneumonitis or pulmonary fibrosis with pulmonary symptoms
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04462952
Start Date
June 24 2020
End Date
September 22 2021
Last Update
July 25 2022
Active Locations (1)
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1
Research Site
Chūōku, Japan, 104-0045