TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT04074343|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma GastroEsophageal Cancer||Drug: TAS-102 Drug: Irinotecan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Multicenter Study of TAS-102 in Combination With Irinotecan in Patients With Advanced Recurrent or Unresectable Gastric and Gastroesophageal Adenocarcinoma After at Least One Line of Treatment With a Fluoropyrimidine and Platinum Containing Regimen|
|Actual Study Start Date :||August 28, 2019|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: TAS-102 and Irinotecan
Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days.
- Percentage of Participants with Progression-free Survival at 6 Months [ Time Frame: 6 Months ]This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined as death, radiographic progression or clinical deterioration attributed to disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of an least 5 mm and/or appearance of new lesions.
- Percentage of Grade 3-5 Adverse Events [ Time Frame: 8 Weeks ]To evaluate the tolerability of administering TAS-102 in combination with Irinotecan in patients with advanced recurrent or unresectable gastric and gastroesophageal adenocarcinoma for the first 2 cycles of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
- Overall Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan [ Time Frame: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. ]To assess the overall response rate to the combination of TAS-102 and Irinotecan. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
- Overall Survival of Patients Who Received TAS-102 and Irinotecan [ Time Frame: From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first. ]To evaluate overall survival in patients with advanced recurrent or unresectable and gastroesophageal adenocarcinoma treated with this combination of TAS-102 and Irinotecan.
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): NCT04074343
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvinefirstname.lastname@example.org|
|Contact: University of California Irvine Medical|
|United States, California|
|Chao Family Comprehensive Cancer Center, University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Farshid Dayyani, MD, PhD 877-827-8839 email@example.com|
|UC Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Kris Curl-Johnston 916-734-3604|
|Principal Investigator: May Cho|
|Principal Investigator:||Farshid Dayyani, MD, PhD||Chao Family Comprehensive Cancer Center|