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

NCT01233375 | Completed Phase 2

• 1 other identifier: CO-101-003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

cancer; metastatic; pancreatic; pancreas; adenocarcinoma; gemcitabine; human equilibrative nucleoside transporter-1 (hENT1); CO-1.01; CO-101; CO101; Stage 4; Stage IV; Gemcitabine-Refractory; Second-Line Therapy

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (CR, PR, or SD) using RECIST 1.1

  Every 8 weeks until disease progression

Secondary Outcomes (8)

• 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

Study Arms (1)

CO-1.01

EXPERIMENTAL

Drug: CO-1.01

Interventions

CO-1.01 DRUG

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 mg/m2) for Cycle 3 and subsequent cycles.

CO-1.01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gemcitabine-refractory metastatic ductal adenocarcinoma of the pancreas
• 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
• No hENT1 expression in primary or metastatic tumor sample, confirmed with IHC by a core pathology laboratory prior to study entry also eligible
• Performance Status (ECOG) 0 or 1
• Age ≥18 years
• Palliative radiotherapy (if administered) ≥2 weeks prior to CO-1.01
• Adequate hematological and biological function, with no residual gemcitabine-related toxicity
• Written consent on an Institutional Review Board (IRB)-approved IC Form prior to any study-specific evaluation

You may not qualify if:

• Patients who have had stable disease, partial response or complete response to first line gemcitabine-based therapy
• First-line chemotherapy regimen that does not contain gemcitabine
• First-line treatment discontinued due to intolerable gemcitabine-induced toxicity
• Second or subsequent line therapy for advanced disease. Prior exposure to CO-1.01 or prior randomization in a protocol studying CO-1.01 (e.g.,Protocol CO-101-001)
• Tumor that cannot be evaluated for hENT1 expression or that has hENT1 staining in \>50% of cells
• Symptomatic brain metastases
• Concomitant treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment \[except corticosteroids and megestrol acetate\], or immunotherapy) ≤14 days prior to CO-1.01
• Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures are not allowed \<14 days prior to CO-1.01 administration; stenting procedures are permissible at any time prior to dosing; in all cases, the patient must be sufficiently recovered and stable
• History of allergy to gemcitabine or eggs
• 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 dose of CO-1.01)
• Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism)
• Any other reason for which the investigator considers the patient should not participate in the study

Sponsors & Collaborators

• Clovis Oncology, Inc.: lead

Study Sites (13)

Arizona Cancer Center at University of Arizona

Tucson, Arizona, 85724, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Palm Beach Institute / Collaborative Research Group

Boynton Beach, Florida, 33425, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Piedmont Healthcare Research Institute (PHRI)

Atlanta, Georgia, 30309, United States

Location

Norton Cancer Institute Research Program

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Columbia University Medical Center, Milstein Hospital

New York, New York, 10032, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232-1305, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Adenocarcinoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Eileen O'Reilly, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: November 3, 2010
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

US (13)