CancerPhase 1NCT00875264
Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
A Phase 1 study testing CEP-11981 (kinase inhibitor) in people with Cancer, run by Cephalon.
Trial summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities of CEP-11981 in patients with advanced, relapsed/refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CEP-11981 (kinase inhibitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jun 2011
- 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
- The patient:
- has a histologically or cytologically confirmed solid tumor that has relapsed or is refractory. Additionally, the tumor must be considered unresponsive or poorly responsive to accepted treatment modalities.
- has a life expectancy of at least 12 weeks.
- has an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2.
- has normal neurologic examination findings. Patients having neurologic signs and symptoms indicative of brain metastases must undergo magnetic resonance imaging (MRI) to rule out brain metastases.
- has fully recovered from any prior surgical procedure(s).
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- has fully recovered from reversible side effects of prior therapy for cancer including radiation therapy, chemotherapy, and immunotherapy.
- is in appropriate health as determined by medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry and hematology tests, and urinalysis.
- if a woman of childbearing potential (not surgically sterile or who are not 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
- if a man, not surgically sterile or who is capable of producing offspring, must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- is willing and able to comply with study restrictions and to return to the clinic for evaluations (including follow-up).
Who cannot join
- The patient:
- has any of the following hematologic values: absolute neutrophil count (ANC) less than 1500/mm3, platelet count less than 100000/mm3, hemoglobin less than 9 g/dL.
- has any of the following hepatic function values: bilirubin greater than 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the ULN in the absence of known hepatic metastases, or ALT or AST greater than 3.0 times the ULN in the presence of known hepatic metastases.
- has a serum creatinine value greater than 1.5 mg/dL.
- has known cerebral metastases.
- is currently on warfarin or heparin therapy.
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- has any pre-existing coagulopathy, recent hemoptysis, gross hematuria, or gastrointestinal bleeding, and a history of a clinically significant cardiovascular or cerebrovascular event within 6 months prior to study entry.
- has uncontrolled hypertension defined as a blood pressure measurement greater than 150 mm Hg systolic or 90 mm Hg diastolic with medication.
- is receiving any other antineoplastic treatment for solid tumors. (Continuing hormonal treatment is permitted.)
- has received any investigational drug within the past 4 weeks.
- has previously been enrolled in the study or received CEP-11981.
- has known hypersensitivity to gelatin or lactose monohydrate.
- is a woman who is pregnant or lactating.
- has taken a medication known to be a potent inducer of CYP1A2, CYP2C8, or CYP3A4 within 4 weeks prior to the first dose of study drug.
- has taken a medication known to be a potent inhibitor of CYP1A2, CYP2C8, or CYP3A4 within 2 weeks prior to the first dose of study drug.
About this study
Official title: An Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities of CEP-11981 in patients with advanced, relapsed/refractory solid tumors.
- Conditions
- Cancer
- Being tested
- CEP-11981 (kinase inhibitor)
- Keywords
- CEP-11981, TIE-2, VEGF-R
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEP-11981 (kinase inhibitor)Drug
Patients will be treated with oral CEP-11981 once daily for 28 days, followed by a treatment-free period of 14 days. This 42-day (6-week) period will constitute 1 cycle. The starting dose for the study will be 3 mg/m2. Dose escalation from this starting dose follows a modified Fibonacci sequence.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | At least one 6-week (42-day) cycle in which patients will be treated daily with CEP-11981 for 28 days, followed by a treatment-free period of 14 days. Receives: Drug: CEP-11981 (kinase inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of CEP-11981, as defined in the Study Protocol.
Measured: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
Secondary outcomes (3)
Tumor response or progression using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Measured: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
Measurement of Pharmacokinetic parameters
Measured: Cycle 1 (42 days) and Day 1 of Cycle 2
Safety and tolerability of CEP-11981
Measured: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startSep 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875264
- Sponsor's protocol ID
- C11981/1047/ON/US
- Status last verified
- Jul 2012
- First submitted
- 1 Apr 2009
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00875264
- Acronym / sponsor ID
- C11981/1047/ON/US
- Conditions
- Cancer
- Keywords
- CEP-11981, TIE-2, VEGF-R
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Apr 2009 (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 primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities of CEP-11981 in patients with advanced, relapsed/refractory solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CEP-11981 (kinase inhibitor)At least one 6-week (42-day) cycle in which patients will be treated daily with CEP-11981 for 28 days, followed by a treatment-free period of 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- has a histologically or cytologically confirmed solid tumor that has relapsed or is refractory. Additionally, the tumor must be considered unresponsive or poorly responsive to accepted treatment modalities.
- has a life expectancy of at least 12 weeks.
- has an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2.
- has normal neurologic examination findings. Patients having neurologic signs and symptoms indicative of brain metastases must undergo magnetic resonance imaging (MRI) to rule out brain metastases.
- has fully recovered from any prior surgical procedure(s).
Key exclusion criteria (15 listed)
- has any of the following hematologic values: absolute neutrophil count (ANC) less than 1500/mm3, platelet count less than 100000/mm3, hemoglobin less than 9 g/dL.
- has any of the following hepatic function values: bilirubin greater than 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the ULN in the absence of known hepatic metastases, or ALT or AST greater than 3.0 times the ULN in the presence of known hepatic metastases.
- has a serum creatinine value greater than 1.5 mg/dL.
- has known cerebral metastases.
- is currently on warfarin or heparin 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 |
|---|---|---|
| CEP-11981 (kinase inhibitor)Patients will be treated with oral CEP-11981 once daily for 28 days, followed by a treatment-free period of 14 days. This 42-day (6-week) period will constitute 1 cycle. The starting dose for the study will be 3 mg/m2. Dose escalation from this starting dose follows a modified Fibonacci sequence. | Drug | 1 |
Primary outcome
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of CEP-11981, as defined in the Study Protocol.
Time frame: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
3 secondary outcomes
Tumor response or progression using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Time frame: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
Measurement of Pharmacokinetic parameters
Time frame: Cycle 1 (42 days) and Day 1 of Cycle 2
Safety and tolerability of CEP-11981
Time frame: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
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 25 Jul 2012.
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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.
Sponsor's Medical Expert study director
Cephalon
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CEP-11981 (kinase inhibitor) in people with Cancer, run by Cephalon.
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 15 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 25 Jul 2012. 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 maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of CEP-11981, as defined in the Study Protocol. (time frame: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle). 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 25 Jul 2012.