NeoplasmsPhase 1NCT00676910
A Research Study of JNJ-26854165 to Determine the Safety and Dose in Patients With Advanced Stage or Refractory Solid Tumors.
A Phase 1 study testing JNJ-26854165 in people with Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess the safety of JNJ-26854165 (a new drug in development for cancer) in patients with advanced or refractory solid tumors on the maximum dose tolerated by these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- JNJ-26854165
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Feb 2010
- 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 solid malignancy, in advanced, incurable stage or not responsive to available therapies
- performance status (based on the Eastern Cooperative Oncology Group assessments) of <= 2
- life expectancy > 3 months
- must consent to skin biopsies
- must meet protocol-defined criteria for lab assessments and heart function.
Who cannot join
- Known central nervous system metastasis
- chemotherapy, radiotherapy, immunotherapy or use of any investigational agent within 2 weeks before dosing
- treatment within last 6 months or expected to require treatment with amiodarone derivates during study participation
- currently treated and/or expected to require treatment with warfarin/coumarine derivates during study participation
- history of uncontrolled heart disease or uncontrolled arterial hypertension
- eye abnormality at screening examination
- >70% stenosis of lumen on Carotid duplex assessment at screening.
About this study
Official title: A Phase I Study to Determine the Safety, Pharmacology, and Pharmacodynamics of JNJ26854165 in Subjects With Advanced Stage and/or Refractory Solid Tumors
The purpose of this study is to assess the safety of JNJ-26854165 (a new drug in development for cancer) in patients with advanced or refractory solid tumors on the maximum dose tolerated by these patients.
Read the detailed description
JNJ-26854165 is a new drug in development and belongs to a class of drugs that act on the specific protein present in cells. It may stop cancer cells from growing or kill cancer cells. In this study, the safety (the effect on the body) of the JNJ-26854165 in patients with advanced or refractory solid tumors will be examined. The effect (if any) of JNJ-26854165 on the disease will be assessed throughout the study. The maximum dose tolerated by these patients will be determined.
The dose of JNJ 26854165 will start low and will be increased during the study. The drug will be taken by mouth every day in each 21-day cycle. The dose each patient receives will be assigned at enrollment. Patients who enroll at a later time may receive a higher dose. If patients do not have severe side effects at a certain dose level, the next group of 3 to 6 patients will get a higher dose. The dose will increase until some patients have severe side effects. The dose will be then decreased and 3 to 6 patients will receive the highest amount of drug where non-severe side effects were observed.
The amount of JNJ 26854165 in the blood will be measured and the effect of JNJ 26854165 on the disease will also be monitored. The effect of food on the absorption, break down and elimination of the drug will be studied in some patients. At some dose levels, the possible interaction of JNJ 26854165 with medications frequently used in cancer patients will be examined and patients at these dose levels will be asked to take a single dose of three additional drugs (dextromethorphan hydrobromide (30mg), tolbutamide (250mg), and midazolam (5mg) "cocktail") on 2 study days, which will all be supplied by the study doctor.
Patients will be screened for eligibility up to 4 weeks before the study drug is administered. During Cycle 1 patients will be observed as inpatients for at least 12 hours after administration of the drug on 3 or 4 days and will be required to visit the study site on 2 additional days. One additional visit is required for patients in whom the food effect or interaction with other medications will be examined. During Cycle 2, patients are required to visit the study center on 2 days. During all cycles after Cycle 2, patients are required to visit the study center on 1 day. Fourteen days after the last dose of JNJ-26854165, the patient will be invited for a follow-up visit which will include tests for safety and the effect of the drug on the disease. The proposed starting dose of JNJ-26854165 is 4 mg/day as a single oral dose. JNJ26854165 will be provided in a glass vial with tear-off cap placed in a child resistant pouch so that the drug may be taken at home. Patients will take JNJ-26854165 each day while in the study. Treatment may continue as long as there is benefit and there are no unacceptable side effects as assessed by the study doctor.
- Conditions
- Neoplasms
- Being tested
- JNJ-26854165
- Keywords
- Advanced Cancer, Malignancies, Neoplasms, Incurable Solid Cancers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-26854165Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.
Secondary outcomes (1)
Determine how JNJ-26854165 is absorbed, broken down and eliminated and the effect of food on these processes. Explore how JNJ-26854165 effects the body and the disease.Determine how JNJ-26854165 interacts with other specific drugs.
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 startNov 2006
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT00676910
- Sponsor's protocol ID
- CR012745
- Status last verified
- Mar 2010
- First submitted
- 8 May 2008
- Last updated
- 26 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Safety, Pharmacology, and Pharmacodynamics of JNJ26854165 in Subjects With Advanced Stage and/or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00676910
- Acronym / sponsor ID
- CR012745
- Conditions
- Neoplasms
- Keywords
- Advanced Cancer, Malignancies, Neoplasms, Incurable Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Feb 2010 (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 the safety of JNJ-26854165 (a new drug in development for cancer) in patients with advanced or refractory solid tumors on the maximum dose tolerated by these patients.
Detailed description
JNJ-26854165 is a new drug in development and belongs to a class of drugs that act on the specific protein present in cells. It may stop cancer cells from growing or kill cancer cells. In this study, the safety (the effect on the body) of the JNJ-26854165 in patients with advanced or refractory solid tumors will be examined. The effect (if any) of JNJ-26854165 on the disease will be assessed throughout the study. The maximum dose tolerated by these patients will be determined.
The dose of JNJ 26854165 will start low and will be increased during the study. The drug will be taken by mouth every day in each 21-day cycle. The dose each patient receives will be assigned at enrollment. Patients who enroll at a later time may receive a higher dose. If patients do not have severe side effects at a certain dose level, the next group of 3 to 6 patients will get a higher dose. The dose will increase until some patients have severe side effects. The dose will be then decreased and 3 to 6 patients will receive the highest amount of drug where non-severe side effects were observed.
The amount of JNJ 26854165 in the blood will be measured and the effect of JNJ 26854165 on the disease will also be monitored. The effect of food on the absorption, break down and elimination of the drug will be studied in some patients. At some dose levels, the possible interaction of JNJ 26854165 with medications frequently used in cancer patients will be examined and patients at these dose levels will be asked to take a single dose of three additional drugs (dextromethorphan hydrobromide (30mg), tolbutamide (250mg), and midazolam (5mg) "cocktail") on 2 study days, which will all be supplied by the study doctor.
Patients will be screened for eligibility up to 4 weeks before the study drug is administered. During Cycle 1 patients will be observed as inpatients for at least 12 hours after administration of the drug on 3 or 4 days and will be required to visit the study site on 2 additional days. One additional visit is required for patients in whom the food effect or interaction with other medications will be examined. During Cycle 2, patients are required to visit the study center on 2 days. During all cycles after Cycle 2, patients are required to visit the study center on 1 day. Fourteen days after the last dose of JNJ-26854165, the patient will be invited for a follow-up visit which will include tests for safety and the effect of the drug on the disease. The proposed starting dose of JNJ-26854165 is 4 mg/day as a single oral dose. JNJ26854165 will be provided in a glass vial with tear-off cap placed in a child resistant pouch so that the drug may be taken at home. Patients will take JNJ-26854165 each day while in the study. Treatment may continue as long as there is benefit and there are no unacceptable side effects as assessed by the study doctor.
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)
- Confirmed solid malignancy, in advanced, incurable stage or not responsive to available therapies
- performance status (based on the Eastern Cooperative Oncology Group assessments) of <= 2
- life expectancy > 3 months
- must consent to skin biopsies
- must meet protocol-defined criteria for lab assessments and heart function.
Key exclusion criteria (7 listed)
- Known central nervous system metastasis
- chemotherapy, radiotherapy, immunotherapy or use of any investigational agent within 2 weeks before dosing
- treatment within last 6 months or expected to require treatment with amiodarone derivates during study participation
- currently treated and/or expected to require treatment with warfarin/coumarine derivates during study participation
- history of uncontrolled heart disease or uncontrolled arterial hypertension
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-26854165 | Drug | – |
Primary outcome
Determine the safety of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.
1 secondary outcome
Determine how JNJ-26854165 is absorbed, broken down and eliminated and the effect of food on these processes. Explore how JNJ-26854165 effects the body and the disease.Determine how JNJ-26854165 interacts with other specific drugs.
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 Mar 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-26854165 in people with Neoplasms, 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 5 inclusion and 7 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 Mar 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 of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.. 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 Mar 2010.