A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

NCT01801930 Phase 1 COMPLETED Results posted

To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

Details

Lead sponsor	Otsuka Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2013-03
Completion	2015-01

Conditions

• Colorectal Cancer

Interventions

• OCV-103 and OCV-104
• OCV-103 and OCV-104
• OCV-103 and OCV-104
• OCV-103 and OCV-104

Primary outcomes

• Dose Limiting Toxicity (DLT) — Day 29
  \[Definition of DLT\] Any of the following adverse events (AEs) that occurred by Day 29 of Cycle 1 and for which a causal relationship to OCV-C02 could not be ruled out: * Grade 3 or higher non-hematological toxicities (except for injection site reaction and laboratory abnormalities lasting \< 7 days without clinical symptoms) * The following hematological toxicities: Grade 4 or higher anemia, Grade 4 or higher neutropenia or lymphocytopenia lasting 7 days, Grade 3 or higher febrile neutropenia, Grade 4 or higher platelet count decreased. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version). In addition, a DLT-equivalent treatment-emergent adverse event (TEAE) was defined as a DLT occurred during the extend treatment period (at Cycle 2 and thereafter).

Countries

Japan