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Solid Tumors or Mantle Cell LymphomaPhase 1NCT01345357

Study of CEP-9722 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors or Mantle Cell Lymphoma

A Phase 1 study testing CEP-9722, Gemcitabine and Cisplatin in people with Solid Tumors or Mantle Cell Lymphoma, run by Cephalon at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to determine the maximum tolerated dose (MTD) of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors or Mantle Cell Lymphoma
What is being tested?
CEP-9722, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesin 2 countries
Study dates
May 2011to Jan 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

  • Written informed consent is obtained. The patient has a either a histologically or cytologically confirmed malignant advanced solid tumor or a mantle cell lymphoma (and has experienced failure of as least 1 previous therapy) and the patient may benefit from the combination of gemcitabine and cisplatin.
  • The patient has measurable or nonmeasurable disease evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
  • The patient is a man or woman at least 18 years of age.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The patient has a life expectancy of 12 weeks or more.
  • The patient has adequate hematologic assessments and adequate renal and hepatic function as specified in the study protocol
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  • The patient has audiogram results without clinically significant abnormalities.
  • The patient may have had chemotherapy provided that at least 3 weeks have elapsed and prior sequelae have resolved. If the patient has had prior radiation (curative or palliative) 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 hormonal therapy for at least 1 week, with the exception of patients with prostate cancer, who may continue hormonal therapy.
  • Written informed consent is obtained.
  • 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

  • With the exception of cancer, the patient has any serious or uncontrolled surgical, medical, or psychiatric history that could prevent compliance with study procedures, or compromise the integrity of the study.
  • The patient has any of the protocol specified risk factors for Torsade de Pointes
  • The patient has a brain lesion requiring systemic therapy with corticosteroids or anti-convulsive agents.
  • The patient has previous hypersensitivity reactions to 1 or more of the components of the CEP-9722, gemcitabine, or cisplatin drug products.
  • 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 or has participated in another interventional clinical study within 4 weeks prior to enrollment.
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  • The patient has any malabsorption syndrome and/or prior gastrectomy
  • The patient has a concomitant uncontrolled and/or chronic infection or severe systemic disease.
  • The patient has had previous treatment with another poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor.
  • The patient is unable to swallow tablets.
  • The patient cannot interrupt continuous treatment with proton pump inhibitors and/or H2 receptor antagonists.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

France2 sites

  • Teva Investigational Site 1

    Nantes

  • Teva Investigational Site 2

    Villejuif

Other trials in France

Belgium1 site

  • Teva Investigational Site 3

    Brussels

Other trials in Belgium

About this study

Official title: A Dose-Escalation Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP 1 and PARP 2 Inhibitor) in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors or Mantle Cell Lymphoma

The primary objective of the study is to determine the maximum tolerated dose (MTD) of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma.

Being tested
CEP-9722, Gemcitabine, Cisplatin
Keywords
Solid tumors, mantle cell lymphoma, Gemcitabine, Cisplatin, Cancer, Neoplasms, Antineoplastic agents
Medical subject headings
Lymphoma, Mantle-Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEP-9722Drug

    CEP-9722 will be administered orally from day 2 through day 7 of each cycle beginning with cycle 2. The starting dose will be 150 mg twice daily. Following cycle 2, the dose will either be decreased to 150 mg daily or increased to 200 mg twice daily in a cohort of 3 to 4 new patients. Subsequent cycles will increase the dose by 100 mg twice daily in cohorts of 3 to 4 patients (with criteria to expand to 6 patients) to a maximum of 400 mg twice daily. Patients must receive CEP-9722 to remain in the study. Once treatment with CEP-9722 is discontinued, patients will withdraw from the study.

  • GemcitabineDrug

    Gemcitabine will be administered at 1250 mg/m^2 intravenously on day 1 and day 8 of each 21-day cycle. Dosage reduction may be applied on day 8 (within a cycle) or on day 1 of the next cycle based upon the grade of toxicity experienced by the patient.

  • CisplatinDrug

    Cisplatin will be administered at 75 mg/m^2 intravenously on day 1 of each cycle, after the infusion of gemcitabine. Dosage reduction may be applied on day 1 of the next cycle based upon the grade of toxicity experienced by the patient.

Study groups in NCT01345357
Study groupRoleWhat they receive
CEP-9722 in combination with Gemcitabine and CisplatinExperimentalStudy drugs will be administered in cycles of 21 days for up to 6 cycles. CEP-9722 treatment will be initiated at cycle 2. After cycle 3, patients may discontinue gemcitabine and/or cisplatin for reasons of tolerability, at the discretion of the investigator.
Receives: Drug: CEP-9722; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of the maximum tolerated dose (MTD) of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma.

    To determine the maximum tolerated dose of CEP-9722, as defined by dose-limiting toxicities (DLTs) reported during the second 21-day treatment cycle (the first cycle of CEP-9722 administration).

    Measured: Baseline and endpoint (as soon as possible after Day 21 of the last cycle)

Secondary outcomes (5)

  1. Evaluate the safety and tolerability of CEP-9722 in combination with gemcitabine and cisplatin

    Assessed by the occurrence of adverse events, clinical laboratory test results, vital signs measurements, electrocardiogram (ECG) findings, physical examination findings, and concomitant medication usage. Creatinine clearance will be calculated according to the Cockroft-Gault formula. An audiogram will be performed at screening and repeated during the study if clinically relevant according to the investigator. Pts who complete or withdraw from treatment will have final procedures/assessments performed as soon as possible, after day 21 of the last cycle, at the end-of-treatment visit.

    Measured: During the entire study, a minimum of 6 wks (two 21-day cycles) up to a maximum of 18 wks (six 21-day cycles).

  2. Cmax pharmacokinetics parameter

    To characterize the pharmacokinetics profile of CEP-8983 (the active moiety of CEP-9722) following administration of CEP-9722, through measurement of the Maximum observed drug Concentration (Cmax).

    Measured: Days 2 and 7 of Cycle 2 and Day 7 of Cycle 3

  3. AUC pharmacokinetics parameter

    To characterize the pharmacokinetics profile of CEP-8983 (the active moiety of CEP-9722) following administration of CEP-9722, through measurement of the Area Under the plasma concentration-time Curve (AUC).

    Measured: Days 2 and 7 of Cycle 2 and Day 7 of Cycle 3

  4. Pharmacodynamics assessment

    To determine the extent of poly-adenosine diphosphate ribose polymerase (PARP) inhibition in peripheral blood mononuclear cells following administration of CEP-9722

    Measured: Screening and Day 2 of Cycle 2 at predose, and at 2 and 6 hours after administration of CEP-9722

  5. Efficacy - will be assessed by Tumor response evaluation of each patient

    Tumor response will be determined using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines, when possible for patients with solid tumors. For patients with mantle tumors, tumor response may be evaluated by the International Working Group criteria.

    Measured: Screening, cycles 3 and 6, and every 2 cycles after cycle 6 until disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2012
  4. Study completionJan 2013

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345357
Sponsor's protocol ID
C9722/1092
Other IDs
2010-023658-36
Status last verified
Jan 2013
First submitted
19 Apr 2011
Last updated
18 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CEP-9722, Gemcitabine and Cisplatin in people with Solid Tumors or Mantle Cell Lymphoma, run by Cephalon at 3 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 12 inclusion and 11 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 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Belgium. 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 the maximum tolerated dose (MTD) of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma. (time frame: Baseline and endpoint (as soon as possible after Day 21 of the last cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01345357.

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 18 Jan 2013.

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