PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Advanced Breast Carcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Prostate Carcinoma
- Prognostic Stage IV Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Stage IV Prostate Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
- Unresectable Solid Neoplasm
- Stage IIIC Prostate Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Triple-Negative Breast Carcinoma
- Castration-Resistant Prostate Carcinoma
- Stage IIIB Prostate Cancer AJCC v8
- Metastatic Breast Carcinoma
- Stage IVB Prostate Cancer AJCC v8
- Metastatic Prostate Carcinoma
- Metastatic Malignant Solid Neoplasm
- Prognostic Stage III Breast Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of PI3Kbeta inhibitor AZD8186 (AZD8186) when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors. II. To assess the safety and tolerability of ...
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of PI3Kbeta inhibitor AZD8186 (AZD8186) when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors. II. To assess the safety and tolerability of AZD8186 when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. Ia. To assess the objective response rate (ORR) of AZD8186 when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors. Ib. To assess the clinical benefit rate at 24 weeks of AZD8186 when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors. II. To investigate a drug-drug interaction between docetaxel and AZD8186 and correlate drug exposure with pharmacodynamics response. EXPLORATORY OBJECTIVES: I. Examine the pattern of co-mutated genes in PTEN or PIK3CB mutated tumors and their association with treatment response or resistance. II. Describe possible mechanisms of acquired resistance to PI3Kbeta inhibition. III. Evaluation of protein expression of the PTEN gene and its association with treatment response or resistance. IV. Examine isoform-specific AKT inhibition and other downstream target modulation from PI3Kbeta inhibition with AZD8186. OUTLINE: This is a dose-escalation study of PI3Kbeta inhibitor AZD8186. Patients receive docetaxel intravenously (IV) over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 orally (PO) twice daily (BID) for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 3 months.
Tracking Information
- NCT #
- NCT03218826
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alison M Schram JHU Sidney Kimmel Comprehensive Cancer Center LAO
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