Up to 18 women with ovarian cancer will administer up to two injections of SPL-108 daily in combination with weekly doses of Paclitaxel. They will be monitored for safety and efficacy for up to 6 months, until disease progression or unacceptable toxicity.
This is an open-label 2-arm trial. Eligible subjects will be screened and enrolled sequentially into 1 of 2 Arms: Arm I: N=6 to 12 subjects, Safety Phase * Cohort 1 SPL-108 x 1 injection daily + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles * Cohort 2 SPL-108 BID + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles For Arm I, at least 1 week will elapse between Dose 1 for each subject. In Cohort 1, 3 subjects will be enrolled: if 1 dose-limiting toxicity (DLT) occurs, 3 subjects will be added at this dose level; if 0/3 or 1/6 DLTs occur, Cohort 2 will initiate enrolling subjects; if 2 or more DLTs occur at this dose level, subjects will not be enrolled in Cohort 2 and the trial will be terminated. In Cohort 2, 3 subjects will be enrolled: if 1 DLT occurs, 3 subjects will be added at this dose level; if 0/3 or 1/6 DLTs occur, Arm II will initiate enrolling subjects at the SPL-108 BID dose; if 2 or more DLTs occur, Arm II will initiate enrolling subjects at the SPL-108 dose one time each day. Arm II: N=up to 12, Exploratory Expansion Phase • Cohort 3: SPL-108 daily dose (to be determined in Arm I) + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles. A Safety Committee will meet at the end of each Arm I Cohort as well as periodically to review safety data and make recommendations for trial progression. The primary efficacy outcome, Response Evaluation Criteria in Solid Tumors Committee (RECIST 1.1) criteria, will be assessed on Day 15 of Cycles 2, 4, and 6.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Subcutaneous injection of 150 mg administered either one time or two times per day.
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Incidence of Adverse Events (Safety)
Includes adverse events, laboratory data, physical examination findings, vital signs, weight and ECOG Performance Status
Time frame: Until dose-limiting toxicity, disease progression or 6 months
Response to Investigational Product
Objective response (OR) through imaging assessments
Time frame: Until dose-limiting toxicity, disease progression or 6 months
Response to Investigational Product
Objective response (OR) through changes in CA 125 levels
Time frame: Until dose-limiting toxicity, disease progression or 6 months
Response to Investigational Product
Objective response (OR) as assessed through changes in Quality of Life (FACT-O Questionnaire)
Time frame: Until dose-limiting toxicity, disease progression or 6 months
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