TAS102 in Combination With NAL-IRI in Advanced GI Cancers
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|ClinicalTrials.gov Identifier: NCT03368963|
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : August 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenocarcinoma Gastric Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Non-Resectable Cholangiocarcinoma Stage IV Colorectal Cancer Stage IV Gastric Cancer Stage IV Pancreatic Cancer Stage IVA Colorectal Cancer Stage IVB Colorectal Cancer Stage III Colorectal Cancer Stage III Gastric Cancer Stage III Pancreatic Cancer Unresectable Digestive System Adenocarcinoma Unresectable Pancreatic Carcinoma||Drug: Nanoliposomal Irinotecan Drug: Trifluridine and Tipiracil Hydrochloride||Phase 1 Phase 2|
I. Determine the recommended phase II dose for the combination of TAS-102 and nanoliposomal irinotecan (nanoliposomal [nal]-IRI). (Phase I)
II. Evaluate the activity of the combination of TAS102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer. (Phase II)
I. Define the toxicity profile of the combination of TAS-102 and nal-IRI.
II. Evaluate the response duration, progression free, and overall survival of the combination of TAS-102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive nanoliposomal irinotecan intravenously (IV) over 90 minutes on day 1 and trifluridine/tipiracil hydrochloride combination agent TAS-102 orally (PO) twice daily (BID) on days 1-5. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 8 or 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Trifluridine/Tipiracil (TAS102) in Combination With Nanoliposomal Irinotecan (NAL-IRI) in Advanced GI Cancers|
|Actual Study Start Date :||January 30, 2018|
|Estimated Primary Completion Date :||November 28, 2021|
|Estimated Study Completion Date :||November 28, 2022|
Experimental: Treatment (Nal-IRI, TAS-102)
Patients receive nanoliposomal irinotecan IV over 90 minutes on day 1 and combination of trifluridine/tipiracil hydrochloride combination agent TAS-102 PO BID on days 1-5. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Nanoliposomal Irinotecan
Drug: Trifluridine and Tipiracil Hydrochloride
- Incidence of adverse events of trifluridine/tipiracil hydrochloride combination agent TAS-102 in combination with nanoliposomal irinotecan [ Time Frame: Up to 3 years after end of treatment ]Assessed using Common Terminology Criteria for Adverse Events version 4.0.
- Overall response rate based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 3 years after end of treatment ]Defined as the proportion of patients who achieved a complete response (complete response: disappearance of all target tumors) or a partial response (partial response: ≥ 30% decrease in the sum of the longest diameters of target tumors).
- Progression free survival [ Time Frame: Up to 3 years after end of treatment ]Will be evaluated.
- Response duration [ Time Frame: From initial response until documented tumor progression, assessed up to 3 years ]Will be estimated by Kaplan-Meier method. P values will be two-sided with significance level of .05.
- Response rate [ Time Frame: Up to 3 years after end of treatment ]Response assessment will be done according to RECIST 1.1 criteria. A repeat imaging scan of the same modality and technique will be repeated after 4 weeks for confirmation of response.
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): NCT03368963
|Contact: Olatunji B. Alese, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Hospital Midtown||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Autumn Lunceford 404-686-1638 email@example.com|
|Emory University Hospital/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: KJ Lee 404-778-3173 firstname.lastname@example.org|
|Emory Saint Joseph's Hospital||Recruiting|
|Atlanta, Georgia, United States, 30342|
|Contact: Alicia Escobar 678-843-7029 email@example.com|
|Contact: Lauryn Taylor 678-843-7544 firstname.lastname@example.org|
|Principal Investigator:||Olatunji B. Alese, MD||Emory University|