An Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer

Cephalon0 sites43 target enrollmentSeptember 2007

ConditionsCancer

InterventionsCEP-11981 (kinase inhibitor)

DrugsCEP-11981 (kinase inhibitor)

Overview

Phase: Phase 1
Intervention: CEP-11981 (kinase inhibitor)
Conditions: Cancer
Sponsor: Cephalon
Enrollment: 43
Primary Endpoint: Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of CEP-11981, as defined in the Study Protocol.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

June 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cephalon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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).
•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.

Exclusion Criteria

•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.
•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.

Arms & Interventions

1

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.

Intervention: CEP-11981 (kinase inhibitor)

Outcomes

Primary Outcomes

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

Secondary Outcomes

Tumor response or progression using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.(At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle)
Measurement of Pharmacokinetic parameters(Cycle 1 (42 days) and Day 1 of Cycle 2)
Safety and tolerability of CEP-11981(At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle)