A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).

• Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H&E stain) to ensure sufficient material is available for later hENT1 analysis.

• Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.

• Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.

• CT scan ≤30 days prior to randomization

• Performance Status (ECOG) 0 or 1.

• Estimated life expectancy ≥ 12 weeks.

• Age ≥ 18 years.

• Adequate hematological and biological function.

• Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.

Exclusion Criteria:

• Prior palliative chemotherapy for pancreatic cancer.

• Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.

• Symptomatic brain metastases.

• Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.

• Concomitant treatment with prohibited medications.

• History of allergy to gemcitabine or eggs.

• Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).

• Any disorder that would hamper protocol compliance.

• Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.

• Females who are pregnant or breastfeeding.

• Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.

• Any other reason the investigator considers the patient should not participate in the study.