Protein Kinase InhibitorsPhase 1NCT00676299
A Safety and Dose-finding Study of JNJ-26483327, a Drug in Development for Cancer, for Patients With Advanced and/or Refractory Solid Malignancies.
A Phase 1 study testing JNJ-26483327 in people with Protein Kinase Inhibitors and Antineoplastic Protocols, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for the safety of the drug in patients with advanced solid tumors that have not responded or are no longer responding to available therapies. The absorption, breakdown and elimination of the drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protein Kinase Inhibitors, Antineoplastic Protocols, Clinical Trial, Phase 1
- What is being tested?
- JNJ-26483327
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Jul 2008
- 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
- Confirmed diagnosis of solid malignancy that is advanced or refractory and progressing and for which standard treatments do not exist or are no longer effective
- radiological assessment of disease within 4 weeks of first study drug administration
- overall health status as determined by the Eastern Cooperative Oncology Group (ECOG) < = 2
- life expectancy > 3 months
- adequate gastrointestinal absorption and ability to swallow
- left ventricular ejection fraction (LVEF) > 50% and protocol-defined criteria for laboratory tests.
Who cannot join
- Cancer has spread to the central nervous system
- chemotherapy, radiotherapy, immunotherapy within 4 weeks before study drug administration or incomplete recovery from preceding surgery or toxicity of prior anticancer therapy (excluding peripheral neuropathy and alopecia)
- history of uncontrolled heart disease as defined in the protocol
- history of pulmonary fibrosis
- acute infection requiring systemic therapy.
About this study
Official title: An Open-label, Phase I Study to Determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, Administered to Subjects With Advanced Stage and/or Refractory Solid Malignancies
The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for the safety of the drug in patients with advanced solid tumors that have not responded or are no longer responding to available therapies. The absorption, breakdown and elimination of the drug will also be studied.
Read the detailed description
JNJ-26483327, a multi-targeted reversible kinase inhibitor, is a new drug in development for treatment of cancer. This study will test the safety (the effect on the body) of JNJ-26483327 and the highest dose of JNJ-26483327 that patients with advanced cancer can tolerate will be determined. Antitumor activity of JNJ-26481585 will be evaluated.
JNJ-26483327 will be administered in a continuous regimen (orally twice daily) in 28-day treatment cycles. The dose of JNJ-26483327 will start low and will be increased during the study in groups of 1 to 6 patients. If a patient or a group of patients does not have severe side effects, the next group of patients will get a higher dose. The dose will increase until some patients have severe side effects. The dose will then be decreased to a dose level where severe side effects are observed in less than 1/3 of patients. Once a safe dose level has been determined an additional group of 12-18 patients will be treated. The amount of JNJ-26483327 in the blood will be measured and the effect of the disease will be evaluated in all patients.
Patients will be screened for eligibility within 4 weeks before study treatment is given. The treatment will consist of 28-day treatment cycles in a continuous twice daily dosing regimen.
During Cycle 1, patients are required to stay in the hospital for 2-3 nights and 2 full days. In addition there are 5 daytime visits during Cycles 1 and 2 (combined) that may take up to 6 hours after the morning dose. From Cycle 3 onwards, one hospital visit is required for each cycle of treatment.
Throughout the study, especially during Cycles 1 and 2, patients will undergo frequent blood and urine tests, procedures to assess safety including heart function, and tests to assess the course of the patient's illness. The duration of treatment will depend on adverse effects and whether there is benefit from the treatment. Two weeks after the last dose of the study drug, patients are required to return to the study site for follow-up assessments. Patients will take JNJ-26483327 capsules by mouth twice a day throughout treatment. Patients will be allowed to continue at the same dose level as long as there are no unacceptable side effects, and there is benefit to the patient based on the study doctor's evaluations.
- Conditions
- Protein Kinase Inhibitors, Antineoplastic Protocols, Clinical Trial, Phase 1, Maximum Tolerated Dose, Pharmacokinetics, Advanced Malignancies
- Being tested
- JNJ-26483327
- Keywords
- Advanced Solid Cancers, Refractory Solid Cancers, Protein Kinase Inhibitors, Phase 1 Study, Oral Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-26483327Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety (effects on the body) and the maximum tolerated dose of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 taken by patients as an oral capsule is absorbed, broken down and eliminated.
Secondary outcomes (1)
Assess the anti-cancer activity of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 works in patients with cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startAug 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein Kinase InhibitorsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676299
- Sponsor's protocol ID
- CR011881
- Status last verified
- Apr 2010
- First submitted
- 8 May 2008
- Last updated
- 26 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study to Determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, Administered to Subjects With Advanced Stage and/or Refractory Solid Malignancies
- ClinicalTrials.gov ID
- NCT00676299
- Acronym / sponsor ID
- CR011881
- Conditions
- Protein Kinase Inhibitors, Antineoplastic Protocols, Clinical Trial, Phase 1, Maximum Tolerated Dose, Pharmacokinetics, Advanced Malignancies
- Keywords
- Advanced Solid Cancers, Refractory Solid Cancers, Protein Kinase Inhibitors, Phase 1 Study, Oral Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Study start
- Aug 2006
- Study completion
- Jul 2008 (actual)
- First posted
- 13 May 2008 (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 JNJ-26483327 (a drug in development for cancer) for the safety of the drug in patients with advanced solid tumors that have not responded or are no longer responding to available therapies. The absorption, breakdown and elimination of the drug will also be studied.
Detailed description
JNJ-26483327, a multi-targeted reversible kinase inhibitor, is a new drug in development for treatment of cancer. This study will test the safety (the effect on the body) of JNJ-26483327 and the highest dose of JNJ-26483327 that patients with advanced cancer can tolerate will be determined. Antitumor activity of JNJ-26481585 will be evaluated.
JNJ-26483327 will be administered in a continuous regimen (orally twice daily) in 28-day treatment cycles. The dose of JNJ-26483327 will start low and will be increased during the study in groups of 1 to 6 patients. If a patient or a group of patients does not have severe side effects, the next group of patients will get a higher dose. The dose will increase until some patients have severe side effects. The dose will then be decreased to a dose level where severe side effects are observed in less than 1/3 of patients. Once a safe dose level has been determined an additional group of 12-18 patients will be treated. The amount of JNJ-26483327 in the blood will be measured and the effect of the disease will be evaluated in all patients.
Patients will be screened for eligibility within 4 weeks before study treatment is given. The treatment will consist of 28-day treatment cycles in a continuous twice daily dosing regimen.
During Cycle 1, patients are required to stay in the hospital for 2-3 nights and 2 full days. In addition there are 5 daytime visits during Cycles 1 and 2 (combined) that may take up to 6 hours after the morning dose. From Cycle 3 onwards, one hospital visit is required for each cycle of treatment.
Throughout the study, especially during Cycles 1 and 2, patients will undergo frequent blood and urine tests, procedures to assess safety including heart function, and tests to assess the course of the patient's illness. The duration of treatment will depend on adverse effects and whether there is benefit from the treatment. Two weeks after the last dose of the study drug, patients are required to return to the study site for follow-up assessments. Patients will take JNJ-26483327 capsules by mouth twice a day throughout treatment. Patients will be allowed to continue at the same dose level as long as there are no unacceptable side effects, and there is benefit to the patient based on the study doctor's evaluations.
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)
- Confirmed diagnosis of solid malignancy that is advanced or refractory and progressing and for which standard treatments do not exist or are no longer effective
- radiological assessment of disease within 4 weeks of first study drug administration
- overall health status as determined by the Eastern Cooperative Oncology Group (ECOG) < = 2
- life expectancy > 3 months
- adequate gastrointestinal absorption and ability to swallow
Key exclusion criteria (5 listed)
- Cancer has spread to the central nervous system
- chemotherapy, radiotherapy, immunotherapy within 4 weeks before study drug administration or incomplete recovery from preceding surgery or toxicity of prior anticancer therapy (excluding peripheral neuropathy and alopecia)
- history of uncontrolled heart disease as defined in the protocol
- history of pulmonary fibrosis
- acute infection requiring systemic therapy.
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 |
|---|---|---|
| JNJ-26483327 | Drug | – |
Primary outcome
Determine the safety (effects on the body) and the maximum tolerated dose of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 taken by patients as an oral capsule is absorbed, broken down and eliminated.
1 secondary outcome
Assess the anti-cancer activity of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 works in patients with cancer.
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 26 Apr 2010.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-26483327 in people with Protein Kinase Inhibitors and Antineoplastic Protocols, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 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 26 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Determine the safety (effects on the body) and the maximum tolerated dose of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 taken by patients as an oral capsule is absorbed, broken down and eliminated.. 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 26 Apr 2010.