Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Solid Neoplasm
  • Refractory Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm
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 safety and tolerability of olaparib in sequential treatment with adavosertib (AZD1775). II. To establish the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of this sequential schedule in patients with advanced solid tumors in a post-poly adenosine ...

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of olaparib in sequential treatment with adavosertib (AZD1775). II. To establish the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of this sequential schedule in patients with advanced solid tumors in a post-poly adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi) population. III. To assess the safety and toxicity profile of the sequential treatment of olaparib and AZD1775 in a post-PARPi population. SECONDARY OBJECTIVES: I. To assess putative predictive biomarkers of response and resistance to the sequential treatment of olaparib and AZD1775 in a post-PARPi population. II. To evaluate a novel experimental trial design involving sequential dosing of olaparib and AZD1775 in a post-PARPi population. III. To observe and record anti-tumor activity. OUTLINE: This is a dose-escalation study of adavosertib. Patients receive olaparib orally (PO) twice daily (BID) on days 1-5 and 15-19 of each cycle and adavosertib PO once daily (QD) on days 8-12 and 22-26 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3-6 months for up to 2 years.

Tracking Information

NCT #
NCT04197713
Collaborators
Not Provided
Investigators
Principal Investigator: Timothy A Yap University of Texas MD Anderson Cancer Center LAO