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Recruiting Phase 1 NCT04693468

Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial

Trial Parameters

Condition Advanced Malignant Solid Neoplasm
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 111
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-12-01
Completion 2027-12-31
Interventions
AxitinibCrizotinibPalbociclib Isethionate

Brief Summary

This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book. PARP inhibitors, such as talazoparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Palbociclib, axitinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib in combination with palbociclib, axitinib, or crizotinib may help control locally advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion Criteria: 1. Pathogenic or likely pathogenic germline or somatic gene defect as determined by local assessment and classification in at least one of the following: * Defect in DNA Damage Response (DDR) genes specified below for each cohort or other related genes at the discretion of the principal investigator in consultation with the MD Anderson Cancer Center Institute for Personalized Cancer Therapy Precision Oncology Decision Support (PODS) group. See below for additional eligibility guidance for Arms A - C: * Eligibility for Arm A (Talazoparib + Palbociclib): * Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes at the discretion of the principal investigator, or * MYC-aberrant solid tumors (e.g. overexpression, amplification, mutation) * Eligibility for Arm B (Talazoparib + Axitinib): * Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes at the discretion of the principal investigato

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