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Metastatic Pancreatic AdenocarcinomaPhase 2NCT01233375

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

A Phase 2 study testing CO-1.01 in people with Metastatic Pancreatic Adenocarcinoma, run by Clovis Oncology, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
CO-1.01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
13 sitesUnited States
Study dates
Apr 2011to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Piedmont Healthcare Research Institute (PHRI)

    Atlanta, Georgia, 30309

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114

  • Palm Beach Institute / Collaborative Research Group

    Boynton Beach, Florida, 33425

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Norton Cancer Institute Research Program

    Louisville, Kentucky, 40202

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Columbia University Medical Center, Milstein Hospital

    New York, New York, 10032

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232-1305

  • Arizona Cancer Center at University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
CO-1.01
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
Medical subject headings
Neoplasms, Neoplasm Metastasis, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CO-1.01Drug

    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.

Study groups in NCT01233375
Study groupRoleWhat they receive
CO-1.01ExperimentalNot described
Receives: Drug: CO-1.01

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Every 8 weeks until disease progression

Secondary outcomes (8)

  1. Overall Response Rate (ORR)

    Measured: Every 8 weeks

  2. CA 19-9 response rate

    Measured: Every 4 weeks

  3. Progression-free survival (PFS)

    Measured: Every 8 weeks

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Every week

  5. Overall survival (OS)

    Measured: 3, 6, 9, and 12 months

  6. Median progression-free survival

    Measured: 3, 6, 9, and 12 months

  7. Median overall survival

    Measured: 3, 6, 9, and 12 months

  8. Duration of response

    Measured: Every 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2010 (estimated)
  2. Study startApr 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01233375
Sponsor's protocol ID
CO-101-003
Status last verified
Mar 2019
First submitted
26 Oct 2010
Last updated
11 Mar 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CO-1.01 in people with Metastatic Pancreatic Adenocarcinoma, run by Clovis Oncology, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (CR, PR, or SD) using RECIST 1.1 (time frame: Every 8 weeks until disease progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01233375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.

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