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A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with RAS wild-type metastatic colorectal cancer refractory to standard chemotherapy

ABSTRACT: Interventions: Panitumumab+TAS-102 -Panitumumab 6mg/kg/ q2w -TAS-102 35mg/m2 (Day1-5, Day8-12) Primary outcome(s): Phase I: DLT rate (1st course: 4 weeks) Phase II: PFS rate at 6 months Study Design: Single arm Non-randomized

DISEASE(S): Unresectable Advanced Colorectal Cancer

PROVIDER: 2635158 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: investigational material(s) Generic name etc : panitumumab, TAS-102 INN of investigational material : panitumumab, trifluridine + tipiracil Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Panitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m^2 given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course). control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : - Primary outcome(s): safety Number of Participants With Dose Limiting Toxicity (DLT) with Panitumumab plus TAS-102 Combination Therapy Timeframe: Up to approximately 1 month DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia for more than 7 days under maximum supportive therapy; 2. Febrile neutropenia; 3. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 4. If Course 2 was not initiated within 14 days due to AE related to the protocol treatment; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (eg, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant. efficacy Progression Free Survival (PFS) Rate at 6 Months Timeframe: Up to 6 months PFS rate at 6 months was defined as the crude rate of surviving participants who survived or were not determined as progressive at 6 months from the day of enrollment. Although the subjects who had no imaging data on progression at 6 months after enrollment or the subjects who had lost to follow-up were included in the denominator, these subjects were not handled as progression-free. Study Design: Exploratory Study

Dataset Information

A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with RAS wild-type metastatic colorectal cancer refractory to standard chemotherapy

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