MelanomaPhase 2NCT00083239
Study of Talabostat in Advanced Melanoma
A Phase 2 study testing talabostat (PT-100) tablets in people with Melanoma and Skin Cancer, run by Point Therapeutics at 6 sites in United States.
Trial summary
The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Skin Cancer
- What is being tested?
- talabostat (PT-100) tablets
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 6 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
- Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002)
- Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins
- ECOG Performance Status of 0, 1, or 2
- Expected survival ≥12 weeks
- Written informed consent
Who cannot join
- More than 1 prior chemotherapy or biotherapy regimen for Stage IV melanoma
- Radiation therapy to >50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
- Clinically significant laboratory abnormalities
- CNS metastases
- 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
Show all 9Show fewer
- 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 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
- Pregnant or lactating women.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109-0473
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322-1013
University of Chicago
Chicago, Illinois, 60637
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582
About this study
The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.
- Conditions
- Melanoma, Skin Cancer
- Being tested
- talabostat (PT-100) tablets
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talabostat (PT-100) tabletsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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)
Sponsor and investigators
- Lead sponsor
- Point Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083239
- Sponsor's protocol ID
- PTH-301
- Status last verified
- Jun 2007
- First submitted
- 14 May 2004
- 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
- Study of Talabostat in Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00083239
- Acronym / sponsor ID
- PTH-301
- Conditions
- Melanoma, Skin Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Point TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 18 May 2004 (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 antitumor activity and safety of talabostat in patients with metastatic melanoma.
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 (5 listed)
- Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002)
- Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins
- ECOG Performance Status of 0, 1, or 2
- Expected survival ≥12 weeks
- Written informed consent
Key exclusion criteria (9 listed)
- More than 1 prior chemotherapy or biotherapy regimen for Stage IV melanoma
- Radiation therapy to >50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
- Clinically significant laboratory abnormalities
- CNS metastases
- 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 (PT-100) tablets | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2007.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
6 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 (PT-100) tablets in people with Melanoma and Skin Cancer, run by Point Therapeutics at 6 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 5 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: finished, 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 6 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.
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.