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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00875264
First received: April 1, 2009
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: CEP-11981 (kinase inhibitor)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Measurement of Pharmacokinetic parameters [ Time Frame: Cycle 1 (42 days) and Day 1 of Cycle 2 ] [ Designated as safety issue: No ]
  • Safety and tolerability of CEP-11981 [ Time Frame: At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key 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 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).
  • 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).

Key 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875264

Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00875264     History of Changes
Other Study ID Numbers: C11981/1047/ON/US
Study First Received: April 1, 2009
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
CEP-11981
TIE-2
VEGF-R

ClinicalTrials.gov processed this record on November 27, 2014