Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
With
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of ipatasertib in combination with paclitaxel and carboplatin as neoadjuvant chemotherapy for ovarian cancer. II. To determine the feasibility of the treatment regimen once the MTD is estimated. III. To assess the toxicities of ipatasertib in combination with paclitaxel and carboplatin by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. SECONDARY OBJECTIVE: I. Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to interval debulking surgery (IDS). TRANSLATIONAL RESEARCH OBJECTIVES: I. To evaluate the change of phosphorylated (p)PRAS40 expression in the pre-treatment tumor versus (vs.) on-treatment tumor. II. To identify the pharmacokinetics of ipatasertib in the tissue and blood. III. To correlate antitumor response with genomic alterations in PI3K pathway genes (PTEN, PIK3CA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1). IV. To correlate antitumor response with transcriptomic alterations in PI3K pathway genes (PTEN, PIK3CA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1). V. To correlate response with PTEN loss. OUTLINE: This is a dose-escalation study of ipatasertib followed by a dose-expansion study. Patients receive paclitaxel intravenously (IV) at 175 mg/m\^2 over 3 hours and carboplatin IV at AUC 5 over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ipatasertib orally (PO) once daily (QD) until 24 hours before surgery in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
