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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
Teva Investigational Site 10689
Chicago, Illinois, United States
Teva Investigational Site 10687
Philadelphia, Pennsylvania, United States
Teva Investigational Site 10686
San Antonio, Texas, United States
Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 8 months
Time to Response (TTR)
The time interval from the date of first dose to the first documented response (complete or partial response)
Time frame: 8 months
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)
Time to Progression (TTP)
The time interval from date of first dose to first documented disease progression
Time frame: 8 months
Progression-free Survival (PFS)
Time interval from date of first does to first documented disease progression or death from any cause (whichever occurs first)
Time frame: 10 months
Time to New Metastases (TTNM)
Time interval from date of first dose to first documented new metastatic lesion not reported at baseline
Time frame: 8 months
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