MelanomaPhase 2NCT00062491
Study of Karenitecin (BNP1350) to Treat Malignant Melanoma
A Phase 2 study testing Karenitecin (BNP1350) in people with Melanoma and Neoplasm, run by BioNumerik Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Karenitecin (BNP1350)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Nov 2005
- 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
- Confirmed diagnosis of malignant melanoma
- Measurable disease
- Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN
- No prior treatment with other camptothecin drug.
- ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C
- ECOG Performance Status 0-1
- Negative pregnancy test for female patients
Trial locations and contacts
1 site in 1 country.
United States1 site
For Information call 210-614-1701 for a site near you
Tampa, Florida, 33612
About this study
Official title: Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.
- Being tested
- Karenitecin (BNP1350)
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karenitecin (BNP1350)Drug
Karenitecn (1.0 mg/m2) administered as a single daily 60-minute intravenous infusion for 5 consecutive days repeated every 21 days (1 treatment cycle). Patients who respond (CR< PR, SD) can continue treatment for 6 cycles, unless unacceptable toxicity develops. Treatment will be discontinued if progressive disease or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Karenitecin (BNP1350) Receives: Drug: Karenitecin (BNP1350) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
Measured: start of treatment until progressive disease
Secondary outcomes (4)
Objective Tumor Response Rate
Measured: Start of treatment to date of response
Duration of Response
Measured: Date of response to date of progressive disease
Overall Survival
Measured: Randomization to date of death from any cause
Progression Free Survival
Measured: Randomization to disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (estimated)
- Study startMay 2002
- Primary completionJun 2003
- Study completionNov 2005
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)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Crown Bioscience
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062491
- Sponsor's protocol ID
- KTN23106
- Status last verified
- Mar 2020
- First submitted
- 6 Jun 2003
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00062491
- Acronym / sponsor ID
- KTN23106
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Crown Bioscience
- Study start
- May 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 12 Jun 2003 (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 evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Karenitecin (BNP1350)Karenitecin (BNP1350) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Karenitecin (BNP1350)Karenitecn (1.0 mg/m2) administered as a single daily 60-minute intravenous infusion for 5 consecutive days repeated every 21 days (1 treatment cycle). Patients who respond (CR< PR, SD) can continue treatment for 6 cycles, unless unacceptable toxicity develops. Treatment will be discontinued if progressive disease or unacceptable toxicity develops. | Drug | 1 |
Primary outcome
Overall Response
Time frame: start of treatment until progressive disease
4 secondary outcomes
Objective Tumor Response Rate
Time frame: Start of treatment to date of response
Duration of Response
Time frame: Date of response to date of progressive disease
Overall Survival
Time frame: Randomization to date of death from any cause
Progression Free Survival
Time frame: Randomization to disease progression
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 12 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Karenitecin (BNP1350) in people with Melanoma and Neoplasm, run by BioNumerik Pharmaceuticals, Inc. at 1 site 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?
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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Overall Response (time frame: start of treatment until progressive disease). 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 12 Mar 2020.