Clinical Trials Logo
  1. Home
  2. Malignant Solid Neoplasm
  3. NCT05142241

Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial

Malignant Solid Neoplasm Clinical Trial

Official title:
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 2 Talazoparib and Temozolomide

Clinical Trial Summary

This phase II trial tests whether combination of talazoparib and temozolomide works to shrink tumors in patients with rare cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Talazoparib is an inhibitor of poly adenosine diphosphate-ribose polymerase (PARP), an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It damages the cell's DNA and may kill cancer cells. Giving talazoparib in combination with temozolomide may help shrink advanced rare cancers or stop them from growing.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with advanced rare cancers who have objective responses (OR) to treatment with temozolomide and talazoparib. EXPLORATORY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months on study agents. II. To identify genomic and transcriptomic determinants of response and resistance in tumor biopsy specimens. III. To examine genomic alterations in circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and circulating tumor cells (CTCs) that may be associated with response or resistance. IV. To evaluate the pharmacodynamic effects of the combination on biomarkers of cell death and epithelial-to-mesenchymal transition in tumor tissue and CTCs. OUTLINE: Patients receive talazoparib orally (PO) once daily (QD) on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and may optionally undergo biopsy and/or blood sample collection at baseline and on the trial. After completion of study treatment, patients are followed up for 30 days or until one of the following occurs: patient enrolls on another protocol, patient receives standard of care, or death, whichever comes first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05142241
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase Phase 2
Start date July 11, 2022
Completion date April 15, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06030427 - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT05660421 - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors Phase 2
Suspended NCT04060849 - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY Phase 1
Recruiting NCT06192875 - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed NCT04122118 - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor N/A
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Active, not recruiting NCT03168737 - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients Phase 1
Active, not recruiting NCT06062901 - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors N/A
Active, not recruiting NCT02444741 - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT04081298 - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors N/A
Active, not recruiting NCT04555837 - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Completed NCT04983901 - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN Phase 2
Active, not recruiting NCT04602026 - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer N/A
Recruiting NCT04871542 - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting NCT04592250 - Financial Toxicity in Cancer Patients
Recruiting NCT05112614 - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting NCT04296305 - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain Phase 4
Recruiting NCT05873608 - Communication Issues in Patient and Provider Discussions of Immunotherapy N/A
Recruiting NCT02464696 - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure N/A