CarcinomaPhase 1NCT00097903
Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer
A Phase 1 study testing Karenitecin (BNP1350) in people with Carcinoma and Carcinoma, Non-Small-Cell Lung, run by BioNumerik Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Karenitecin (BNP1350)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to May 2013
- Phase
- Phase 1
- 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 entering the Phase 1 portion of the study must have a histologically or cytologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no conventional treatment exists.
- Patients entering the Phase 2 portion of the study must have a histologically or cytologically documented diagnosis of advanced (Stage IIIb/IV) NSCLC.
- Patients entering the Phase 1 portion of the study can have either measurable or evaluable disease.
- Patients entering the Phase 2 portion of the study must have measurable disease meeting RECIST criteria.
- Patients must have an ECOG performance status of less than or equal to 1.
- More than 2 weeks must have elapsed since previous chemotherapy and 6 weeks from previous treatment with nitrosoureas or mitomycin-C.
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- Patients must have fully recovered from the toxic effects of prior therapy.
- Patients entering the Phase 1 portion of the study may have received up to two prior chemotherapy programs including adjuvant or neoadjuvant therapy.
- Patients entering the Phase 2 portion of the study may have received only one prior chemotherapy program including adjuvant or neoadjuvant therapy for NSCLC.
- More than 2 weeks must have elapsed since previous radiation therapy and prior radiation must be less than or equal to 15% of the bone marrow.
- Required Initial Laboratory Data: *ANC ≥ 1,500/mm3, *Platelet count ≥ 100,000/mm3, *SGPT < 1.5 times ULN, *Alkaline phosphatase < 2.0 times ULN, *Bilirubin < 1.5 mg/dl, *Serum creatinine < 1.5 times ULN
Who cannot join
- Pregnant or lactating women.
- Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6 months, or uncontrolled arrhythmia.
- Phase 2 no previous or concurrent malignancy
- Central Nervous System (CNS) metastasis if neurologically unstable or requiring steroid use.
- Active infection.
- Known positive HIV status.
- Conditions requiring use of H2 blockers or other antacids.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
About this study
Official title: Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"
The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.
Read the detailed description
Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in patients with advanced solid tumors will be determined.
When the recommended phase 2 dose has been determined, the specified dose will be used to determine if Karenitecin is effective in the treatment of patients with relapsed or refractory non-small cell lung cancer.
- Conditions
- Carcinoma, Carcinoma, Non-Small-Cell Lung
- Being tested
- Karenitecin (BNP1350)
- Keywords
- Carcinoma, Non-Small-Cell Lung, Solid Tumors, Oral
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung
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
Phase 1 study,dose-escalation design
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Karenitecin IV/ Karenitecin tablet Receives: Drug: Karenitecin (BNP1350) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety and determination of MTD, and recommended Phase 2 dose
Measured: throughout study
Secondary outcomes (2)
Pharmacokinetics
Measured: various timepoints
Tumor response
Measured: various timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2004 (estimated)
- Study startMay 2004
- Primary completionOct 2011
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT00097903
- Sponsor's protocol ID
- KTN22208
- Status last verified
- Mar 2020
- First submitted
- 1 Dec 2004
- 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 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"
- ClinicalTrials.gov ID
- NCT00097903
- Acronym / sponsor ID
- KTN22208
- Conditions
- Carcinoma, Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Solid Tumors, Oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Crown Bioscience
- Study start
- May 2004
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Dec 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 determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.
Detailed description
Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in patients with advanced solid tumors will be determined.
When the recommended phase 2 dose has been determined, the specified dose will be used to determine if Karenitecin is effective in the treatment of patients with relapsed or refractory non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Karenitecin (BNP1350)Karenitecin IV/ Karenitecin tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients entering the Phase 1 portion of the study must have a histologically or cytologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no conventional treatment exists.
- Patients entering the Phase 2 portion of the study must have a histologically or cytologically documented diagnosis of advanced (Stage IIIb/IV) NSCLC.
- Patients entering the Phase 1 portion of the study can have either measurable or evaluable disease.
- Patients entering the Phase 2 portion of the study must have measurable disease meeting RECIST criteria.
- Patients must have an ECOG performance status of less than or equal to 1.
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6 months, or uncontrolled arrhythmia.
- Phase 2 no previous or concurrent malignancy
- Central Nervous System (CNS) metastasis if neurologically unstable or requiring steroid use.
- Active infection.
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 BNP1350Phase 1 study,dose-escalation design | Drug | 1 |
Primary outcome
Overall Safety and determination of MTD, and recommended Phase 2 dose
Time frame: throughout study
2 secondary outcomes
Pharmacokinetics
Time frame: various timepoints
Tumor response
Time frame: various timepoints
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 1 study testing Karenitecin (BNP1350) in people with Carcinoma and Carcinoma, Non-Small-Cell Lung, 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?
The sponsor lists 11 inclusion and 8 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Safety and determination of MTD, and recommended Phase 2 dose (time frame: throughout study). 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.