A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma

Launched by CENTOCOR, INC. · Oct 28, 2005

Keywords

ClinConnect Summary

This is a Phase 1/2, multi-center, randomized (the study medication is assigned by chance) study. This study will be conducted in 2 Phases (Phase 1 and Phase 2). Phase 1 of this study will be non-randomized, open-label (all people know the identity of the intervention) and dose-escalation phase. It includes screening period and treatment period, which consists of 2 parts (Part 1 and Part 2). In Part 1, participants will receive 1 of 3 single dose levels of intetumumab \[3 milligram per kilogram (mg/kg), 5 mg/kg or 10 mg/kg\]. Part 2 will include 2 dose cohorts: dacarbazine plus intetumumab ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed melanoma including ocular and mucosal
• • Documented AJCC (American Joint Committee on Cancer) Stage 3 unresectable or Stage 4 melanoma (Phase 1); AJCC Stage 4 melanoma (Phase 2)
• • Radiographically measurable disease or measurable skin lesions
• • Prior chemotherapy for metastatic melanoma will be allowed for Phase 1, while previously untreated for melanoma by chemotherapy will be allowed for Phase 2
• • Agrees to protocol-defined use of effective contraception
• Exclusion Criteria:
• • History of receiving murine or human/murine recombination products of human αν integrins
• • Known human immunodeficiency virus (HIV) positivity and clinically important active infection
• • Presence of bone metastases or malignant effusions (non-measurable lesions) and central nervous system metastases
• • Prior radiation to target lesions
• • Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational therapy and therapeutic use of anticoagulation