A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with colorectal cancer (APOLLON)

ABSTRACT: Intervention name : panitumumab, TAS-102 INN of the intervention : panitumumab, trifluridine + tipiracil Dosage And administration of the intervention : 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 intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - 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

DISEASE(S): Colorectal Cancer

PROVIDER: 2611401 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR