Pancreatic CancerPhase 2NCT00116389
Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
A Phase 2 study testing talabostat mesylate tablets and gemcitabine in people with Pancreatic Cancer and Neoplasm Metastasis, run by Point Therapeutics at 28 sites in United States.
Trial summary
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma
- What is being tested?
- talabostat mesylate tablets and gemcitabine
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 28 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Men or women age ≥18 years
- Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
- Measurable disease defined per RECIST
- Karnofsky Performance Status ≥50
- Expected survival ≥12 weeks
- Provide written informed consent
Who cannot join
- CNS metastases
- Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
- Radiation therapy to >25% of the bone marrow
- Clinically significant laboratory abnormalities
- Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents
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- Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
- Pregnancy or lactation
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
New York Oncology Hematology/Albany Regional Cancer Center
Albany, New York, 12208
Medical Oncology LLC
Baton Rouge, Louisiana, 70809
Billings Clinic
Billings, Montana, 59101
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435
Mary Crowley Medical Research Center
Dallas, Texas, 75201
Texas Oncology, PA, Presbyterian
Dallas, Texas, 75231
Northwest Alabama Cancer Center, PC
Florence, Alabama, 35630
Cancer Center of the Carolinas
Greenville, South Carolina, 29615
Oncology Associates, PC
Hartford, Connecticut, 06106
Baylor College of Medicine
Houston, Texas, 77030
Elkins Pancreas Center
Houston, Texas, 77030
Saint Luke's Episcopal Hospital
Houston, Texas, 77030
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, 46202
Dayton Oncology and Hematology
Kettering, Ohio, 45409
Monmouth Medical Center
Long Branch, New Jersey, 07740
Yagnesh V. Oza, MD
Mount Vernon, Illinois, 62864
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, 35661
Cancer Care Center, Inc.
New Albany, Indiana, 47150
Hematology-Oncology Associates of Rockland
New City, New York, 10956
Cancer Center of Florida
Ocoee, Florida, 34761
Huron Medical Center
Port Huron, Michigan, 48060
Providence Portland Medical Center
Portland, Oregon, 97213-2933
Oregon Clinic, The
Portland, Oregon, 97213
Hematology Oncology Associates of Central Brevard
Rockledge, Florida, 32955
Cancer Care Northwest
Spokane, Washington, 99218
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705
Lawrence M. Stallings, MD
Wooster, Ohio, 44691
Trilogy Cancer Center
Wooster, Ohio, 44691
About this study
Official title: An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.
- Conditions
- Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma
- Being tested
- talabostat mesylate tablets, gemcitabine
- Keywords
- pancreatic cancer, cancer of the pancreas, adenocarcinoma of the pancreas, pancreatic neoplasms, Metastatic pancreatic cancer (Stage IV), Stage IV Adenocarcinoma of the Pancreas
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talabostat mesylate tabletsDrug
gemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month survival
Secondary outcomes (5)
overall survival
progression-free survival (PFS)
quality of life
pain
performance status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2005 (estimated)
Why it stopped: FDA Hold May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Point Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116389
- Sponsor's protocol ID
- PTH-320
- Status last verified
- Jun 2007
- First submitted
- 28 Jun 2005
- Last updated
- 8 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT00116389
- Acronym / sponsor ID
- PTH-320
- Conditions
- Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma
- Keywords
- pancreatic cancer, cancer of the pancreas, adenocarcinoma of the pancreas, pancreatic neoplasms, Metastatic pancreatic cancer (Stage IV), Stage IV Adenocarcinoma of the Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA Hold May 2007
- Enrolment
- 60 participants
- Lead sponsor
- Point TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 29 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women age ≥18 years
- Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
- Measurable disease defined per RECIST
- Karnofsky Performance Status ≥50
- Expected survival ≥12 weeks
Key exclusion criteria (9 listed)
- CNS metastases
- Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
- Radiation therapy to >25% of the bone marrow
- Clinically significant laboratory abnormalities
- Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talabostat mesylate tablets | Drug | – |
| gemcitabine | Drug | – |
Primary outcome
6 month survival
5 secondary outcomes
overall survival
progression-free survival (PFS)
quality of life
pain
performance status
Results and safety
The study was stopped early (reason given: FDA Hold May 2007). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing talabostat mesylate tablets and gemcitabine in people with Pancreatic Cancer and Neoplasm Metastasis, run by Point Therapeutics at 28 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 6 inclusion and 9 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 8 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 (reason given: FDA Hold May 2007). 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?
6 month survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2007.