Solid TumorPhase 1NCT00920595
Study of CEP-9722 as Single-Agent Therapy and as Combination Therapy With Temozolomide in Patients With Advanced Solid Tumors
A Phase 1 study testing CEP-9722 in people with Solid Tumor, run by Cephalon at 2 sites in 2 countries.
Trial summary
An open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of CEP-9722 as single-agent therapy and as combination therapy with temozolomide in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- CEP-9722
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2009to Oct 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 malignant advanced solid tumor considered unresponsive or poorly responsive to accepted treatment modalities.
- The patient has adequate hematologic assessments and adequate renal and hepatic functions as specified in the study protocol.
- The patient has measurable or nonmeasurable disease documented with an appropriate method of evaluation according to disease characteristics.
- The patient has had no chemotherapy for at least 3 weeks and has resolution of prior sequelae. If the patient has had prior curative radiation or prior treatment with nitrosoureas, a minimum of 4 weeks and 6 weeks, respectively, must have elapsed before treatment with CEP-9722.
- The patient has had no immunotherapy, including monoclonal antibody therapy, for at least 4 weeks and no hormonotherapy for at least 1 week, with the exception of patients with prostate cancer, who may continue hormonal therapy.
- The patient has a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
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- The patient has a life expectancy of 12 weeks or more.
- Agreement by women of childbearing potential (not surgically sterile or 2 years postmenopausal) to use a medically accepted method of contraception and continue the use of this method for the duration of the study and for 90 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.
- Agreement by men not surgically sterile or who are capable of producing offspring to practice abstinence or use a barrier method of birth control, and continue use of this method for the duration of the study and for 6 months after participation in the study.
Who cannot join
- The patient has a primary brain tumor whose disease requires a systematic premedication with anticonvulsive agents.
- The patient has baseline cardiac abnormalities outside of the specified study parameters.
- The patient has clinically symptomatic recurrent/progressive brain metastases within 4 weeks (stable sequelae are acceptable).
- The patient has previous hypersensitivity reactions to 1 of the components of CEP-9722, temozolomide, or dacarbazine.
- The patient is a pregnant or breast-feeding woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
- The patient is participating in another interventional clinical study at the time of enrollment, has participated in another interventional clinical study within 4 weeks prior to enrollment, or the patient has previously been already enrolled in this study.
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- The patient has an active gastroduodenal ulcer, uncontrolled high blood pressure, uncontrolled diabetes mellitus, or uncontrolled angina pectoris; has had a recent myocardial infarction; has had a cerebrovascular event within 6 months prior to study entry; or has pre-existing coagulopathy.
- The patient has a concomitant uncontrolled infection or severe systemic disease.
- The patient has a known nephropathy or hepatopathy.
- The patient is receiving concurrent treatment with an antineoplastic agent other than temozolomide.
- The patient has had previous treatment with another PARP inhibitor.
- The patient is unable to swallow capsules.
- The patient has taken any medications which are contraindicated as specified in the study protocol.
- The patient has any serious or uncontrolled nonmalignant medical disorder or psychiatric disorder.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Cephalon Investigational Site
Newcastle upon Tyne, NE7 7DN
About this study
Official title: An Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP-1 and PARP-2 Inhibitor) as Single-Agent Therapy and as Combination Therapy With Temozolomide in Patients With Advanced Solid Tumors
An open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of CEP-9722 as single-agent therapy and as combination therapy with temozolomide in patients with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- CEP-9722
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEP-9722Drug
Starting dose of CEP-9722 is 150 mg/day (total dose). The study consists of a 14-day cycle of CEP-9722 alone, and at least one 28-day cycle of CEP-9722 plus temozolomide (150 mg/m2/day on Days 1-5). Patients who are receiving clinical benefit may receive subsequent cycles of study drug treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CEP-9722 alone and in combination therapy with temozolomide. Receives: Drug: CEP-9722 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerated Dose (MTD) upon Dose Limiting Toxicities (DLT) data
Measured: Up to 42 days
Secondary outcomes (3)
Pharmacokinetic parameters
Measured: Days 1 and 5 of Cycle 1 and on Day 5 of Cycle 2
Pharmacodynamics assay
Measured: Days 1, 5, and 8 of both Cycle 1 and Cycle 2
Efficacy - will be assessed by the proportion of patients who achieve tumor response during the study
Measured: A 14-day cycle and at least one 28-day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, MD, Study director, Cephalon France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920595
- Sponsor's protocol ID
- C9722/1065/PK/FR-UK
- Other IDs
- EudraCT number: 2008-006858-18
- Status last verified
- Aug 2012
- First submitted
- 11 Jun 2009
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP-1 and PARP-2 Inhibitor) as Single-Agent Therapy and as Combination Therapy With Temozolomide in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00920595
- Acronym / sponsor ID
- C9722/1065/PK/FR-UK
- Conditions
- Solid Tumor
- Keywords
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Jun 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.
An open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of CEP-9722 as single-agent therapy and as combination therapy with temozolomide in patients with advanced 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-9722CEP-9722 alone and in combination therapy with temozolomide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient has a histologically or cytologically confirmed malignant advanced solid tumor considered unresponsive or poorly responsive to accepted treatment modalities.
- The patient has adequate hematologic assessments and adequate renal and hepatic functions as specified in the study protocol.
- The patient has measurable or nonmeasurable disease documented with an appropriate method of evaluation according to disease characteristics.
- The patient has had no chemotherapy for at least 3 weeks and has resolution of prior sequelae. If the patient has had prior curative radiation or prior treatment with nitrosoureas, a minimum of 4 weeks and 6 weeks, respectively, must have elapsed before treatment with CEP-9722.
- The patient has had no immunotherapy, including monoclonal antibody therapy, for at least 4 weeks and no hormonotherapy for at least 1 week, with the exception of patients with prostate cancer, who may continue hormonal therapy.
Key exclusion criteria (14 listed)
- The patient has a primary brain tumor whose disease requires a systematic premedication with anticonvulsive agents.
- The patient has baseline cardiac abnormalities outside of the specified study parameters.
- The patient has clinically symptomatic recurrent/progressive brain metastases within 4 weeks (stable sequelae are acceptable).
- The patient has previous hypersensitivity reactions to 1 of the components of CEP-9722, temozolomide, or dacarbazine.
- The patient is a pregnant or breast-feeding woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
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-9722Starting dose of CEP-9722 is 150 mg/day (total dose). The study consists of a 14-day cycle of CEP-9722 alone, and at least one 28-day cycle of CEP-9722 plus temozolomide (150 mg/m2/day on Days 1-5). Patients who are receiving clinical benefit may receive subsequent cycles of study drug treatment. | Drug | 1 |
Primary outcome
Determination of Maximum Tolerated Dose (MTD) upon Dose Limiting Toxicities (DLT) data
Time frame: Up to 42 days
3 secondary outcomes
Pharmacokinetic parameters
Time frame: Days 1 and 5 of Cycle 1 and on Day 5 of Cycle 2
Pharmacodynamics assay
Time frame: Days 1, 5, and 8 of both Cycle 1 and Cycle 2
Efficacy - will be assessed by the proportion of patients who achieve tumor response during the study
Time frame: A 14-day cycle and at least one 28-day 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 16 Aug 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, MD study director
Cephalon France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CEP-9722 in people with Solid Tumor, run by Cephalon at 2 sites in 2 countries.
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 9 inclusion and 14 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 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. 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?
Determination of Maximum Tolerated Dose (MTD) upon Dose Limiting Toxicities (DLT) data (time frame: Up to 42 days). 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 16 Aug 2012.