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Pancreatic CancerPhase 2NCT00493441

AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

A Phase 2 study testing AVN944 in people with Pancreatic Cancer, run by Vertex Pharmaceuticals Incorporated at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study was designed to find the optimum AVN944 dose to use in combination with gemcitabine in patients with pancreatic cancer and see if the combination of the 2 drugs was more effective for treating pancreatic cancer than using gemcitabine alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
AVN944
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
16 sitesUnited States
Study dates
Jun 2007to Dec 2009
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

  • Patients with histologically or cytologically confirmed adenocarcinoma of the pancreas not eligible for curative intent resection with or without adjuvant radiation therapy
  • Measurable disease as defined by RECIST criteria
  • No prior chemotherapy for pancreatic cancer including no prior "radiosensitizing" chemotherapy
  • Patients are candidates to receive gemcitabine as first line treatment for adenocarcinoma of the pancreas
  • Age > 18 years
  • Karnofsky Performance Score of less than or equal to 60
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  • Patients must be recovered from the clinically significant effects of any prior surgery or prior radiotherapy
  • Adequate bone marrow, hepatic and renal function as evidenced by:
  • Serum total bilirubin < 2.0 mg/dL
  • AST/ALT (SGOT/SGPT) < 4X the ULN for the reference lab;
  • Serum creatinine < 2.0 mg/dL;
  • ANC > 1.5 x 109/L;
  • Platelet count > 100 x 109/L,
  • Hgb > 9.0 g/dL
  • Female patients of childbearing potential as well as fertile men and their partners who agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
  • Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.

Who cannot join

  • Patients with a life expectancy < 3 months
  • Patients with known CNS metastases
  • Patients with an uncontrolled active infection
  • Prior treatment with an IMPDH-inhibitor
  • Patients with known hypersensitivity to any of the components of AVN944 or gemcitabine
  • History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers; cervical intraepithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL
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  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to < Grade 2.
  • Patients who are pregnant or lactating
  • Myocardial Infarction within the past 6 months
  • Patients with clinically significant intraventricular conduction delays
  • Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • History of solid organ transplant
  • Known HIV or Hepatitis B or C (active, previously treated or both)
  • Previous treatment under this protocol

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Chattanooga Oncology and Hematology Associates

    Chattanooga, Tennessee, 37404

  • Cleveland Clinic - Taussig Cancer Center

    Cleveland, Ohio, 44195

  • University of Florida - Shands Cancer Center

    Gainesville, Florida, 32610

  • Joliet Oncology and Hematology Associates

    Joliet, Illinois, 60435

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Southern California - Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Sarah Cannon Research Institute -Tennessee Oncology

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06520

  • Columbia University

    New York, New York, 10032

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Virginia Cancer institute

    Richmond, Virginia, 23230

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94115

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Georgetown University, Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase II Study of AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

The study was designed to find the optimum AVN944 dose to use in combination with gemcitabine in patients with pancreatic cancer and see if the combination of the 2 drugs was more effective for treating pancreatic cancer than using gemcitabine alone.

Being tested
AVN944
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • AVN944Drug

    150, 200, 250, 300, or 400 mg q12h

Study groups in NCT00493441
Study groupRoleWhat they receive
TreatmentExperimentalNot described
Receives: Drug: AVN944

What is being measured

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

  1. Safety

    Measured: 4 weeks

  2. Pharmacokinetics

    Measured: Days 1, 8, 15, and 22

Timeline

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

  1. First posted28 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493441
Sponsor's protocol ID
AVN944-006
Status last verified
Sep 2020
First submitted
26 Jun 2007
Last updated
30 Sep 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AVN944 in people with Pancreatic Cancer, run by Vertex Pharmaceuticals Incorporated at 16 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 16 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 was stopped early. Results are not available in the source record.

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?

Safety (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT00493441.

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 30 Sep 2020.

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