This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.
Targeted anticancer drugs have side effects that often result in a poor quality of life, noncompliance, dose decreases, or discontinuation, all of which can affect efficacy. This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an insulin suppressing diet and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
serabelisib administered orally
3 meals consumed daily (i.e., breakfast, lunch, dinner) and optional snacks provided dependent on caloric needs
nab-paclitaxel administered intravenously weekly
University of Alabama
Birmingham, Alabama, United States
Pacific Cancer Specialists
Anaheim, California, United States
Cohorts 1a/1b: Evaluate safety
Incidence of related AEs
Time frame: Through study completion, up to 12 months.
Cohorts 1a/1b: Evaluate compliance
Compliance of Study intervention
Time frame: Through study completion, up to 12 months.
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Cmax.
Standard pharmacokinetic parameters (Cmax)
Time frame: Through study completion, up to 12 months.
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Tmax.
Standard pharmacokinetic parameters (Tmax).
Time frame: Through study completion, up to 12 months.
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring AUC.
Standard pharmacokinetic parameters (AUC).
Time frame: Through study completion, up to 12 months.
Cohorts 2, 3, 4: Use the Objective Response Rate (ORR) to assess the antitumor efficacy of serabelisib in combination with a Study ISD.
Proportion of subjects who have best overall response of either complete response (CR) or partial response (PR)
Time frame: Through study completion, an average of 8 months.
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring ORR.
Proportion of subjects who have best overall response of either CR or PR, as determined by each site.
Time frame: Through study completion, up to 12 months.
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Valkyrie Clinical Trials
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
New Jersey Cancer Care, PA
Belleville, New Jersey, United States
Englewood Health
Englewood, New Jersey, United States
Northwell Health
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 7 more locations
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring PFS.
Time from date of first dose of Study Drug (Visit 1) to the date of first evidence of disease progression or death from any cause (whichever occurs first).
Time frame: Through study completion, up to 12 months.
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring OS.
Overall survival (OS) and landmark survival.
Time frame: Through study completion, up to 12 months.
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring DoR.
Duration of response (DoR)
Time frame: Through study completion, up to 12 months.
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring DCR.
Disease control rate (DCR; CR + PR + stable disease \[SD\])
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Confirm safety
Incidence of related AEs
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Confirm the compliance of study intervention.
Compliance of Study intervention
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring PFS).
Time from the date of first dose of Study Drug (Visit 1) to the date of first evidence of disease progression or death from any cause (whichever occurs first)
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring OS).
OS and landmark survival
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DoR).
DoR
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DCR).
DCR (CR+PR+SD)
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.
Standard PK Parameters (Cmax) in plasma.
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.
Standard PK Parameters (Tmax) in plasma
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.
Standard PK Parameters (AUC) in plasma
Time frame: Through study completion, up to 12 months.
Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.
Serabelisib concentration in tumor tissue
Time frame: Through study completion, up to 12 months.