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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

Phase 2
18 Years
Not Enrolling
Metastatic Pancreatic Adenocarcinoma

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Every 8 weeks until disease progression

Safety Issue:


Principal Investigator

Eileen O'Reilly, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

March 2013

Related Keywords:

  • Metastatic Pancreatic Adenocarcinoma
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Medical College of WisconsinMilwaukee, Wisconsin  53226
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Rocky Mountain Cancer CenterDenver, Colorado  80218
University of MiamiMiami, Florida  33136
Arizona Cancer Center at University of ArizonaTucson, Arizona  85724
Palm Beach Institute / Collaborative Research GroupBoynton Beach, Florida  33425
Piedmont Healthcare Research Institute (PHRI)Atlanta, Georgia  30309
Norton Cancer Institute Research ProgramLouisville, Kentucky  40202
Massachusetts General Hospital (MGH)Boston, Massachusetts  02114
Columbia University Medical Center, Milstein HospitalNew York, New York  10032