Study of AZD1775 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring TP53 Mutation as a Second-line Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02448329|
Recruitment Status : Unknown
Verified May 2019 by Jeeyun Lee, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : May 19, 2015
Last Update Posted : May 20, 2019
This study is a single arm, single center phase II study of AZD1775 in combination with paclitaxel in patients with advanced gastric adenocarcinoma harboring TP53 mutation as a second-line chemotherapy.
Patients will receive AZD 1775 plus weekly paclitaxel combination regimen. The arm is composed of 25 patients.
AZD1775 225 mg BID q 12 hours (x 5 doses) administered days 1~3 + paclitaxel 80 mg/m2 given days 1, 8 and 15 of a 28 day cycle.
Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted at screening every 16 weeks until objective disease progression .
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Adenocarcinoma||Drug: AZD1775 Drug: paclitaxel||Phase 2|
AZD1775 is an inhibitor of Wee1, a protein tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2 (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.
In in vitro and in vivo preclinical models, AZD1775 selectively enhanced chemotherapy induced death of cells deficient in p53 signaling. Tumor context-specific sensitization to the DNA damaging agents gemcitabine and platinums was observed in TOV21G (ovarian carcinoma) cell lines matched for wild type and knock down of p53.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||January 14, 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: AZD1775 in Combination With Paclitaxel
AZD1775 225 mg BID q 12 hours (x 5 doses, 2.5 days) administered days 1~3 Weekly paclitaxel 80 mg/m2 IV on 1, 8 and 15 of a four week l cycle is an widely used dose of paclitaxel given on this schedule in gastric adenocarcinoma patients as second-line therapy.
AZD1775 225 mg BID q 12 hours (x5 doses, 2.5 days) administered days 1~3
paclitaxel 80 mg/m2 given days 1, 8 and 15 of a 28 day cycle
- Objective response rate (ORR) [ Time Frame: 8weeks ]
- Duration of response [ Time Frame: 24weeks ]
- Disease control rate [ Time Frame: 8weeks ]
- Overall survival [ Time Frame: 24weeks ]
- progression-free survival (PFS) [ Time Frame: 24weeks ]
- safety and tolerability measured by Adverse Events,Vital signs,Collection of clinical chemistry/haematology parameters,ECGs [ Time Frame: 24weeks ]
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): NCT02448329
|Contact: yoon jeong Ahn||221487395 ext 82|
|Contact: Jee yun Lee, MD,Ph.D.||234103459 ext 82|
|Korea, Republic of|
|Samsung Medical center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Yoonjeong Ahn 82-2-2148-7395 email@example.com|
|Principal Investigator: Jeeyun Lee, MD,PhD|
|Principal Investigator:||Jee yun Lee, MD,Ph.D.||Samsung Medical Center,Seoul,Korea|