Safety, Tolerance, PK, and Anti-tumour Activity of AZD1775 Monotherapy in Patients With Advanced Solid Tumours
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02482311|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer, TNBC, SCLC, Other Solid Tumours||Drug: AZD 1775||Phase 1|
This study is being conducted in two parts, designated Parts A and B. Part A is a safety lead-in consisting of a cohort of approximately 12 patients with advanced solid tumours.
Part B expansion cohorts will investigate AZD1775 monotherapy in advanced tumour types with molecular biomarkers of interest. The tumour types to be evaluated are: 1) ovarian cancer (BRCA1/2 mutation [PARP-failures]), 2) ovarian cancer (BRCA wild-type) with more than three prior lines of treatment, 3) triple negative breast cancer (TNBC), and 4) small-cell lung cancer (SCLC).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of AZD1775 Monotherapy in Patients With Advanced Solid Tumours|
|Actual Study Start Date :||July 1, 2015|
|Actual Primary Completion Date :||January 25, 2018|
|Actual Study Completion Date :||January 25, 2018|
Single-arm study. AZD1775 will be administered for 3 consecutive days at the start of week 1 and week 2 of each 21-day cycle.
This study will be conducted in two parts, designated Part A and Part B. Part A is a safety lead-in. Part B will commence after the safety lead-in and will investigate the safety and efficacy of AZD1775 monotherapy in expansion cohorts of specific tumour types.
Drug: AZD 1775
AZD1775 will be taken orally approximately every 12 hours over 3 days at the start of week 1 and week 2 of each 21-day cycle (Days 1-3 and 8-10), for a total of 12 doses with each treatment cycle.
AZD1775 should be taken approximately 2 hours before or 2 hours after food.
- Number of treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs) as a measure of safety and tolerability. [ Time Frame: From first dose of study treatment up to last day of Cycle 1 (21 days) ]The AZD1775 dose is considered safe and tolerable if ≤ 1 of 6 patients experiences a DLT.
- Objective Response Rate (ORR) [ Time Frame: Every 6 weeks until treatment discontinuation as defined by RECIST 1.1, projected 12 months. ]The proportion of patients achieving a complete or partial tumour response (CR or PR) according to RECIST 1.1 criteria.
- Disease Control Rate (DCR) [ Time Frame: Every 6 weeks until treatment discontinuation as defined by RECIST 1.1, projected 12 months ]The proportion of patients achieving a complete response (CR) or partial response (PR), or stable disease (SD) according to RECIST v1.1 criteria
- Duration of Response (DoR) [ Time Frame: Every 6 weeks until treatment discontinuation as defined by RECIST 1.1, projected 12 months ]The time from first documented tumor response until the date of documented progression or death from any cause.
- Progression Free Survival (PFS) [ Time Frame: Every 6 weeks until treatment discontinuation as defined by RECIST 1.1, project 12 months. ]Defined as the time from date of first dose of AZD1775 until the date of objective disease progression or death by any cause as defined by RECIST 1.1.
- PK profile: Plasma concentrations of AZD1775 and PK parameters (Cmax, C8hr, tmax, AUC, tlast, t½λz) [ Time Frame: Pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose of AZD1775 during Cycle 1-Day 1 and Cycle 1-Day3 or Day-10 of the safety lead-in part of study ]Blood samples will be collected at various timepoints post-dosing
- QTc prolongation [ Time Frame: ECGs collected pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose in Cycle 1-Day 1 and on Cycle 1-Day 3 or Day 10. ]ECGs will be obtained at various timepoints
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482311
|United States, Arkansas|
|Fayetteville, Arkansas, United States, 72703|
|United States, California|
|La Jolla, California, United States, 92093|
|Los Angeles, California, United States, 90048|
|San Francisco, California, United States, 94115|
|United States, Florida|
|Fort Myers, Florida, United States, 33905|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|Detroit, Michigan, United States, 48201|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28204|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|Greenville, South Carolina, United States, 29605|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Toronto, Ontario, Canada, M5G IX6|
|Principal Investigator:||Todd M. Bauer, MD||SCRI Development Innovations, LLC|