A Multinational, Multicenter, Open-label, Single-arm, Phase II Study of G17DT Immunogen in Combination With Irinotecan in Metastatic Colorectal Carcinoma Refractory to Previous Irinotecan-based Chemotherapy. (CC6)

NCT02118064 Phase 2 COMPLETED

This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy.

Details

Lead sponsor	Cancer Advances Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	161
Start date	2001-03

Conditions

• Colorectal Cancer

Interventions

• G17DT-Irinotecan

Primary outcomes

• Tumor response — up to 12 months
  Evaluate the effect of G17DT-Irinotecan combination therapy on tumor response assessed by magnetic resonance imaging or computed tomography.
• Survival time — up to 12 months
  The vital status of patients was monitored until death or end of the study.
• Number of Patients with Serious and Non-Serious Adverse Events — Up to 12 months
  Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.