ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Advanced Malignant Solid Neoplasm
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Estrogen Receptor Positive
- HER2/Neu Negative
- Metastatic Malignant Solid Neoplasm
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- TP53 wt Allele
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Unresectable Malignant Solid Neoplasm
- Recurrent Breast Carcinoma
- Prognostic Stage IIIB Breast 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. Determine the dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD) of MDM2/MDMX inhibitor ALRN-6924 (ALRN-6924) in combination with paclitaxel in adult patients with advanced or metastatic solid tumors with wild-type (WT) TP53. II. Evaluate the safety and tolera...
PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD) of MDM2/MDMX inhibitor ALRN-6924 (ALRN-6924) in combination with paclitaxel in adult patients with advanced or metastatic solid tumors with wild-type (WT) TP53. II. Evaluate the safety and tolerability of ALRN-6924 in combination with paclitaxel in patients with advanced or metastatic WT TP53 solid tumors. SECONDARY OBJECTIVES: I. Evaluate the anti-tumor activity of ALRN-6924 in combination with paclitaxel in solid tumors (in dose escalation) and hormone-receptor positive breast cancer (in expansion). II. Describe the pharmacokinetics (PK) of ALRN-6924 and paclitaxel in plasma following single and multiple intravenous (IV) infusions (cycle 1 day 1, day [D]2, D15 and cycle 2 D1). EXPLORATORY OBJECTIVES: I. Assess predictive and pharmacodynamic (PD) markers of response. II. Assess the effects of ALRN-6924 and paclitaxel on cell proliferation and apoptosis. III. Assess the effects of ALRN-6924 and paclitaxel on cell-free deoxyribonucleic acid (DNA) (cfDNA) dynamics and macrophage inhibitory cytokine-1 (MIC-1). OUTLINE: This is a dose-escalation study of MDM2/MDMX inhibitor ALRN-6924. Patients receive paclitaxel intravenously (IV) over 1 hour and MDM2/MDMX inhibitor ALRN-6924 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 1 year and then every 3 months thereafter.
Tracking Information
- NCT #
- NCT03725436
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Ecaterina E Dumbrava M.D. Anderson Cancer Center
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