AZD8186 and Paclitaxel in Advanced Gastric Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04001569|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
AZD8186 is an orally-dosed, selective Phosphatidylinositol 3-kinase (PI3K) β/δ inhibitor that binds to PI3Kβ and PI3Kδ, and inhibits kinase activity and downstream pathways in vitro and in vivo. AZD8186 has shown significant anti-tumor activity in PTEN-deficient preclinical models, including prostate, triple negative breast cancer, squamous lung and germinal center diffuse large B-cell lymphoma models. PTEN deficiency is reported in approximately 20% of patients with gastric cancer and in 35-48% of those with human epidermal growth factor receptor 2(HER2)-positive gastric cancer. To date, there have been no clinical trials with AZD8186 alone or in combination with paclitaxel in advanced gastric cancer. Therefore, it is very important to conduct clinical trials of combination therapy of AZD8186 and paclitaxel in patients with metastatic/recurrent gastric cancer who have failed previous therapy, and to identify the clinical factors and biomarkers that predict effects of the combination therapy.
The purpose of the study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and AZD8186 combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line therapy in patients with advanced gastric cancer with PTEN aberrations. This study is divided into Phase 1b and Phase 2.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Stomach Cancer||Drug: AZD8186 in combination with paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase1b/2 Study of AZD8186 in Combination With Paclitaxel in Patients With Advanced Gastric Cancer|
|Actual Study Start Date :||May 14, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
|Experimental: AZD8186 in combination with paclitaxel||
Drug: AZD8186 in combination with paclitaxel
Phase 1b is planned for a 4-stage dose level and the traditional 3+3 design is applied. The RP2D will be determined based on the MTD and toxicity profiles.
In phase 2 part, RP2D from the phase 1b part will be applied.
- Maximal tolerated dose [ Time Frame: 4 weeks ]
- Recommended phase 2 dose [ Time Frame: 4 weeks ]
- Progression-free survival rate [ Time Frame: 4 months ]
- Dose-limiting toxicity [ Time Frame: 4 weeks ]Dose-limiting toxicity (DLT) assessment will be performed during the first cycle in phase 1b part, and is based on NCI-CTCAE (version 4.0).
- Overall survival [ Time Frame: 1-year ]
- Progression-free survival [ Time Frame: 1-year ]
- Objective response rate [ Time Frame: 1-year ]
- Adverse event [ Time Frame: 1-year ]
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): NCT04001569
|Contact: Yong Min Shinfirstname.lastname@example.org|
|Contact: Keun-Wook Lee, MD. & Ph.Demail@example.com|
|Korea, Republic of|
|Hallym University Sacred Heart Hospital||Not yet recruiting|
|Anyang, Gyeonggi-do, Korea, Republic of, 14068|
|Contact: Dae Young Zhang, MD. & Ph.D. firstname.lastname@example.org|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620|
|Contact: Keun-Wook Lee, MD. & Ph.D 82-31-787-7039 email@example.com|
|Asan Medical Center||Not yet recruiting|
|Seoul, Korea, Republic of, 05505|
|Contact: Min-Hee Ryu, MD. & Ph.D. firstname.lastname@example.org|
|Principal Investigator:||Keun-Wook Lee, MD. & Ph.D||Seoul National University Bundang Hospital|