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To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01922752
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: CEP-37440 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Maximum Tolerated Dose of Oral CEP-37440 Administered as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
Study Start Date : July 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: CEP-37440 Drug: CEP-37440

CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily.

Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.





Primary Outcome Measures :
  1. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Time to Response (TTR) [ Time Frame: 8 months ]
    The time interval from the date of first dose to the first documented response (complete or partial response)

  2. Number of participants with adverse events [ Time Frame: From signing of the informed consent to the end of the follow-up visit (approximately Month 10) ]
  3. Time to Progression (TTP) [ Time Frame: 8 months ]
    The time interval from date of first dose to first documented disease progression

  4. Progression-free Survival (PFS) [ Time Frame: 10 months ]
    Time interval from date of first does to first documented disease progression or death from any cause (whichever occurs first)

  5. Time to New Metastases (TTNM) [ Time Frame: 8 months ]
    Time interval from date of first dose to first documented new metastatic lesion not reported at baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.
  • Patients must have evidence of recurrent, locally advanced, or metastatic disease.
  • Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.
  • Patients must have a predicted life expectancy of more than 3 months.
  • Patients must have presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1.
  • Patients must have an ECOG performance score of 0, 1, or 2.
  • Patients with central nervous system (CNS) metastases will be allowed on this study. Patients may have received surgical and/or radiation treatment. The metastases must be neurologically stable, on or off corticosteroids. Patients can have low level, asymptomatic brain lesions that do not require surgical/radiation intervention acutely. Patients with symptomatic lesions with impending neurologic compromise should be appropriately treated with high dose steroids/radiation and may be re-evaluated for this study when neurologically stable.
  • Patients must have completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy and at least 2 to 3 weeks for all other modalities of therapy including chemotherapy, monoclonal antibody therapy, immunotherapy, other investigational drugs, or other kinase inhibitors.
  • Other criteria apply.

Exclusion Criteria:

  • The patient has ongoing or active infection requiring parenteral antibiotics.
  • The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
  • The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
  • The patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.
  • The patient has a primary brain tumor. Patients may have brain metastases from another primary site.
  • The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes.
  • The patient has a prior ALK-inhibitor-related toxicity or any other prior therapy-related acute toxicity that has not resolved prior to the first dose of study drug.
  • Other criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922752


Locations
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United States, Illinois
Teva Investigational Site 10689
Chicago, Illinois, United States
United States, Pennsylvania
Teva Investigational Site 10687
Philadelphia, Pennsylvania, United States
United States, Texas
Teva Investigational Site 10686
San Antonio, Texas, United States
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT01922752     History of Changes
Other Study ID Numbers: C37440/1108
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
CEP-37440
Advanced solid tumors
Metastatic solid tumors

Additional relevant MeSH terms:
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Neoplasms