Metastatic pancreatic cancer MedDRA version: 14.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Product Name: CO-1.01
Product Code: CO-1.01
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: N/A
CAS Number: 210829-30-4
Current Sponsor code: CO-1.00
Other descriptive name: gemcitabin
Sponsors
Clovis Oncology Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for the study if all of the following criteria are met: • 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. - Biopsy from metastases must be obtained =3 months after adjuvant chemotherapy (if applicable). - Paraffin block or freshly fixed tissue sufficient for preparing =6 unstained slides for central storage and subsequent hENT1 analysis is required. • Adjuvant chemotherapy/radiotherapy (if administered) =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, which is defined as the following: Bone marrow function - Neutrophils =1.5 × 10 to the power of 9/L - Platelets >100.0 × 10 to the power of 9/L - Hemoglobin =9 g/dL Hepatic function - AST =2.5 × upper limit of normal (ULN); if liver metastases, =5 × ULN - Bilirubin =1.5 times ULN; if liver metastases, =3 × ULN - Albumin >3 g/dL - PT/PTT within 10% ULN Renal function - Serum creatinine =1.5 × ULN • Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 41
Exclusion criteria
Exclusion criteria: Patients are excluded from the study if any of the following criteria are met: • 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 (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment, or immunotherapy) =30 days prior to randomization. • 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. Prior malignancies allowed irrespective of when they occurred are 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 protocol-specified treatment). Adequate forms of contraception are docuble-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectible contraceptives, interuterine devices; tubal ligation. • Any other reason the investigator considers the patient should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of CO-1.01 and gemcitabine in patients with metastatic pancreatic adenocarcinoma and low human equilibrative nucleoside transporter 1 (hENT1) expression;Secondary Objective: • To compare the efficacy of CO-1.01 and gemcitabine in patients with metastatic pancreatic adenocarcinoma and known hENT1 status (all patients and high hENT1 expression). • To compare the tolerability and toxicity of CO-1.01 with gemcitabine. • To compare changes in pain severity in patients receiving CO-1.01 and gemcitabine. • To compare changes in health status in patients receiving CO-1.01 and gemcitabine. • To perform sparse PK sampling in patients taking CO-1.01 to contribute towards development of a population PK model of CO-1.01. • To evaluate the clinical utility of the hENT1 diagnostic test.;Primary end point(s): The overall survival (OS) in patients with low hENT1 expression ;Timepoint(s) of evaluation of this end point: The primary endpoint analysis will take place when 90 events of death have been observed in the hENT1-low patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • OS in all patients and patients with high hENT1 expression • Objective tumor response rate (ORR), duration of response, and progression free survival (PFS) in patients with measurable/evaluable disease, using RECIST 1.1. • CA 19-9 velocity and response rate. • Drug tolerability and toxicity using clinical AE monitoring, clinical laboratory testing, ECG outcomes, and dose modifications of protocol-specified treatment • Change from baseline in pain severity measured by the worst pain on the Brief Pain Inventory (BPI) short form. • Change from baseline in health status measured by the European Quality of Life-5 Dimension (EQ-5D) instrument and European Quality Visual Analog Scale (EQ VAS) • PK profile of CO-1.01 based on sparse sampling.;Timepoint(s) of evaluation of this end point: The secondary analyses will occur when 90 events of death have been observed in the hENT1-low patients. AEs will be assessed from the time informed consent (IC) is obtained through 28 days after the last protocol-specified treatment administration. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Netherlands, Norway, Russian Federation, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactDr. Lindsey Rolfe
Clovis Oncology UK Ltd
Outcome results
None listed