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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01233375
First received: October 26, 2010
Last updated: June 18, 2013
Last verified: June 2013

October 26, 2010
June 18, 2013
April 2011
March 2013   (final data collection date for primary outcome measure)
Disease Control Rate (CR, PR, or SD) using RECIST 1.1 [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01233375 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (ORR) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • CA 19-9 response rate [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Every week ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Median progression-free survival [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Overall Response Rate (ORR) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • CA 19-9 response rate [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Every week ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Median progression-free survival [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate Efficacy of CO-1.01 as Second Line Therapy for Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma
A Phase II, Open-Label, Multicenter Study to Evaluate the Antitumor Efficacy of CO-1.01 for Infusion as Second-Line Therapy for Gemcitabine- Refractory Patients With Stage IV Pancreatic Adenocarcinoma and No Tumor hENT1 Expression

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Pancreatic Adenocarcinoma
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 mg/m2) for Cycle 3 and subsequent cycles.

Experimental: CO-1.01
Intervention: Drug: CO-1.01
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  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

Exclusion Criteria:

  1. Patients who have had stable disease, partial response or complete response to first line gemcitabine-based therapy
  2. First-line chemotherapy regimen that does not contain gemcitabine
  3. First-line treatment discontinued due to intolerable gemcitabine-induced toxicity
  4. 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)
  5. Tumor that cannot be evaluated for hENT1 expression or that has hENT1 staining in >50% of cells
  6. Symptomatic brain metastases
  7. 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
  8. 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
  9. History of allergy to gemcitabine or eggs
  10. Females who are pregnant or breastfeeding
  11. 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)
  12. 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)
  13. Any other reason for which the investigator considers the patient should not participate in the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01233375
CO-101-003
No
Clovis Oncology, Inc.
Clovis Oncology, Inc.
Not Provided
Principal Investigator: Eileen O'Reilly, M.D. Memorial Sloan-Kettering Cancer Center
Clovis Oncology, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP