Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs
|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: NCT02943733|
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : June 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Neoplasms Cancer Tumors||Drug: TAS-102 Drug: Temozolomide Drug: Filgrastim Drug: Pegfilgrastim||Phase 1|
The study is a two part phase 1B clinical trial consisting of three study periods: a screening period of 14 days or less, a treatment period, and a safety follow-up period 30 days after treatment discontinuation.
Part 1 is a dose finding phase with the objective to assess the safety and tolerability of the proposed drug combination and to identify the maximum tolerated dose (MTD) and a recommended phase 2 dose.
Part 2 is an open-label expansion study, which will enroll patients with metastatic pNETs who have not been previously treated with chemotherapy. Part 2 will obtain further safety data of the proposed drug combination.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors|
|Actual Study Start Date :||August 22, 2017|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: TAS-102 and TMZ
Part 1: dose-escalation phase to determine MTD of TAS-102 in combination with Temozolomide (TMZ). Treatment cycles are 28 days, with TAS-102 administered orally twice daily days 1-5 and 8-12, and TMZ administered orally days 8-12. No treatment medications administered days 13-28 of each cycle. Growth factor support is required during Part 1 and should be dosed per institutional standards.
Part 2: expansion phase to evaluate preliminary efficacy of MTD. Subjects treated with the recommended phase 2 drug doses determined in part 1. Treatment will continue for up to 13 cycles (approx. 12 months). Growth factor support is allowed during Part 2 and should be dosed per institutional standards.
Anti-metabolite agent, taken orally.
Oral chemotherapy drug.
Other Name: TMZ
Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
- Part 1: Maximum Tolerated Dose (MTD) of TAS-102 [ Time Frame: Up to 2 years ]Investigate the safety and determine the MTD of TAS-102 administered in combination with TMZ in patients with advanced NETs. Treatments will continue to disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST).
- Part 2: Overall Response Rate [ Time Frame: Up to 5 years ]Response rate defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR), assessed as per RECIST criteria. Assessments performed using RECIST criteria.
- Part 2: Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]Defined as the time from the start of treatment to the date of first documented progression or any cause of death during the study, assessed according to RECIST. Analyzed using the Kaplan-Meier method.
- Part 2: Overall Survival [ Time Frame: Up to 5 years ]Defined as the time from the start of treatment to the date of expiration. Analyzed using the Kaplan-Meier method.
- Part 2: Disease Control Rate [ Time Frame: Up to 5 years ]Defined as the percentage of patients who achieved complete response, partial response, and stable disease by investigator assessment as per RECIST.
- Part 2: Duration of Response [ Time Frame: Up to 5 years ]Analyzed using the Kaplan-Meier method.
- Part 2: Safety and Tolerability, Assessed per RECIST Criteria [ Time Frame: Up to 5 years ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Part 2: Biochemical Response defined as normalization or >50% reduction in levels of Chromogranin A [ Time Frame: Up to 5 years ]A major biochemical response will be defined as normalization or >50% reduction in levels of Chromogranin A. Chromogranin A is elevated in up to 60% of functioning and nonfunctioning pancreatic endocrine tumors.
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): NCT02943733
|Contact: Cancer Connectemail@example.com|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Cancer Connect 800-622-8922 firstname.lastname@example.org|
|Principal Investigator: Nataliya Uboha|
|Principal Investigator:||Nataliya Uboha, MD||University of Wisconsin, Madison|