Study To Evaluate Efficacy Of CO-1.01 As Second Line Therapy For Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma

Study Overview

Study to Evaluate Efficacy of CO-1.01 as Second Line Therapy for Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma

The purpose of this study is to determine whether CO-1.01 is safe and effective for treating metastatic pancreatic cancer that did not respond to gemcitabine.

Pancreatic tumors with low hENT1 expression may show less benefit from gemcitabine compared with those with higher expression of this nucleoside transporter. Nonclinical studies indicate that CO-1.01, a gemcitabine derivative, is effective independent of such transporters. Thus patients with low or no meaningful expression of hENT1 who failed to respond to gemcitabine might derive benefit from CO1.01 before needing alternative (combination) chemotherapy. Furthermore, the PK profiles of CO-1.01 and gemcitabine are dissimilar and this may confer additional clinical benefit on CO1.01.

Metastatic Pancreatic Adenocarcinoma

DRUG: CO-1.01

CO-101-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-10-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-03-05
First Submitted that Met QC Criteria 2010-11-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-03-11
First Posted (ACTUAL) 2010-11-03	Results First Posted N/A	Last Verified 2019-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CO-1.01	DRUG: CO-1.01 1250 mg/m2/day administered on Days 1, 8, and 15 in 4-week treatment cycles. Patients who have SD or better at the Week 8 assessment and who adequately tolerated the first 2 cycles of treatment may continue CO-1.01 at the same or an increased dose (1400

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CO-1.01

DRUG: CO-1.01

1250 mg/m2/day administered on Days 1, 8, and 15 in 4-week treatment cycles. Patients who have SD or better at the Week 8 assessment and who adequately tolerated the first 2 cycles of treatment may continue CO-1.01 at the same or an increased dose (1400

Primary Outcome Measures	Measure Description	Time Frame
Disease Control Rate (CR, PR, or SD) using RECIST 1.1		Every 8 weeks until disease progression

Secondary Outcome Measures	Measure Description	Time Frame
Overall Response Rate (ORR)		Every 8 weeks
CA 19-9 response rate		Every 4 weeks
Progression-free survival (PFS)		Every 8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Every week
Overall survival (OS)		3, 6, 9, and 12 months
Median progression-free survival		3, 6, 9, and 12 months
Median overall survival		3, 6, 9, and 12 months
Duration of response		Every 8 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

At least 1 measurable lesion according to RECIST 1.1 criteria
Computerized tomography (CT) scan ≤ 28 days prior to CO-1.01
First-line treatment included at least 3 doses of gemcitabine (as monotherapy or combination therapy) with the last dose administered at least 2 weeks prior to CO 1.01
Radiological best response of disease progression after 1st-line treatment (no radiological stable disease or better allowed at any time)
Patients who experienced progressive disease during (neo)-adjuvant gemcitabine-based therapy are also eligible
Patients who have completed previous adjuvant therapy without progression, then subsequently have a radiological best response of disease progression on 1st line gemcitabine for metastatic disease are eligible 2. No hENT1 expression in primary or metastatic tumor sample, confirmed with IHC by a core pathology laboratory prior to study entry also eligible 3. Performance Status (ECOG) 0 or 1 4. Age ≥18 years 5. Palliative radiotherapy (if administered) ≥2 weeks prior to CO-1.01 6. Adequate hematological and biological function, with no residual gemcitabine-related toxicity 7. Written consent on an Institutional Review Board (IRB)-approved IC Form prior to any study-specific evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Eileen O'Reilly, M.D., Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record