Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer (GEN206)

Genmab

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Zalutumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00677924

GEN206

Details and patient eligibility

About

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and Females age ≥ 18 years
2. Confirmed diagnosis of CRC
3. Documented disease progression
4. Failure and/or intolerance to standard chemotherapy

Exclusion criteria

1. Prior treatment with anti-EGFR antibodies other than cetuximab
2. Expected survival < 3 months
3. Clinical significant cardiac disease and/or uncontrolled medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Zalutumumab 8 mg/kg

Experimental group

Description:

Zalutumumab in combination with Irinotecan

Treatment:

Drug: Zalutumumab

Zalutumumab 16 mg/kg

Experimental group

Description:

Zalutumumab in combination with Irinotecan

Treatment:

Drug: Zalutumumab