Brain NeoplasmsPhase 2NCT00062478
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
A Phase 2 study testing Karenitecin (BNP1350) in people with Brain Neoplasms and Malignant Neoplasms, Brain, run by BioNumerik Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Malignant Neoplasms, Brain, Brain Tumors
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Aug 2002
- 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 a newly diagnosed glioblastoma multiforme or recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma.
- Evidence of measurable recurrent or residual primary CNS neoplasm.
- An interval of at least 3 weeks between prior surgical resection or 6 weeks between prior radiotherapy or chemotherapy, and enrollment on this protocol unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy.
- Hematocrit > 29%, ANC > 1,500, platelets > 125,000
- Serum creatinine < 1.5 mg/dl, BUN < 25 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal
- 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
Durham, North Carolina, 27710
About this study
Official title: Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin
The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
- Conditions
- Brain Neoplasms, Malignant Neoplasms, Brain, Brain Tumors
- Being tested
- Karenitecin (BNP1350)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karenitecin (BNP1350)Drug
Also called Karenitecin also referred to as BNP1350
Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Karenitecin for intravenous use Receives: Drug: Karenitecin (BNP1350) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response Rate
Measured: Randomization to end of treatment
Secondary outcomes (2)
Overall Survival
Measured: Randomization to date of death due to any cause
Overall Safety
Measured: Randomization to end of study participation
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 startOct 2001
- Primary completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies 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
- 40 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
- NCT00062478
- Sponsor's protocol ID
- KTN20405
- Status last verified
- Jul 2019
- 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 Treatment of Adults With Primary Malignant Glioma With Karenitecin
- ClinicalTrials.gov ID
- NCT00062478
- Acronym / sponsor ID
- KTN20405
- Conditions
- Brain Neoplasms, Malignant Neoplasms, Brain, Brain Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Crown Bioscience
- Study start
- Oct 2001
- Primary completion
- Aug 2002 (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 safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
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 for intravenous use |
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)Also: Karenitecin also referred to as BNP1350Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity. | Drug | 1 |
Primary outcome
Objective Tumor Response Rate
Time frame: Randomization to end of treatment
2 secondary outcomes
Overall Survival
Time frame: Randomization to date of death due to any cause
Overall Safety
Time frame: Randomization to end of study participation
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 Brain Neoplasms and Malignant Neoplasms, Brain, 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?
Objective Tumor Response Rate (time frame: Randomization to end of treatment). 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.