Clinical Trials Logo

Clinical Trial Summary

This phase I trial finds the best dose and side effects of cabozantinib and pamiparib in treating patients with solid tumors that have spread to other places in the body (advanced) or does not respond to treatment (refractory). Cabozantinib and pamiparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) or maximum administered dose (MAD) and dose-limiting toxic effects (DLTs) of cabozantinib and pamiparib. II. To define the safety profiles of cabozantinib and pamiparib. SECONDARY OBJECTIVES: I. To perform plasma pharmacokinetic analyses of cabozantinib and pamiparib interaction. II. To evaluate patient reported outcomes (PRO). III. To evaluate pre-identified mutations in circulating free deoxyribonucleic acid (DNA) (cfDNA) by next generation sequencing (NGS). IV. To estimate complete responses (CRs), partial responses (PRs), stable disease >= 6 months (SD >= 6months), progression free survival (PFS) and overall survival (OS). V. To relate changes in phosphorylated AKT (pAKT), phosphorylated ERK2 (pERK2), phosphorylated c-MET (pc-MET), phosphorylated PARP1 (PARP1-pY907), phosphorylated histone H2A variant H2AX (gamma-H2AX) and RAD51 in tumor specimens with antitumor efficacy. VI. To relate cancer-associated mutations at baseline with antitumor efficacy. VII. To explore potential biomarkers of acquired resistance by comparing molecular signatures at baseline with those at time of relapse in patients in whom SD >= 6 months/CR/PR or a mixed response are documented, by next-generation deep sequencing or more sophisticated techniques. OUTLINE: This is a dose-escalation study. Patients receive cabozantinib orally (PO) once daily (QD) and pamiparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 6 months. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Malignant Solid Neoplasm
  • Neoplasms
  • Refractory Malignant Solid Neoplasm

NCT number NCT05038839
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Not yet recruiting
Phase Phase 1
Start date October 1, 2021
Completion date June 3, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05039801 - IACS-6274 With or Without Pembrolizumab for the Treatment of Advanced Solid Tumors Phase 1
Suspended NCT03253679 - AZD1775 in Treating Patients With Advanced Refractory Solid Tumors With CCNE1 Amplification Phase 2
Withdrawn NCT03925428 - Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas Phase 1
Not yet recruiting NCT05039632 - NBTXR3, Radiation Therapy, Ipilimumab, and Nivolumab for the Treatment of Lung and/or Liver Metastases From Solid Malignancy Phase 1/Phase 2
Recruiting NCT02389309 - Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors Phase 1
Recruiting NCT03065387 - Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation Phase 1
Active, not recruiting NCT04552704 - CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study Phase 1/Phase 2
Not yet recruiting NCT04939090 - Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients Phase 3
Active, not recruiting NCT03698994 - Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT03210714 - Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT02451553 - Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer Phase 1
Recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Not yet recruiting NCT04090619 - Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Patients and Their Primary Caregivers
Active, not recruiting NCT01480154 - Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer Phase 1
Completed NCT03291938 - IACS-010759 in Advanced Cancers Phase 1
Recruiting NCT01434316 - Veliparib and Dinaciclib in Treating Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04439344 - Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A) Phase 2
Active, not recruiting NCT04439123 - Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) Phase 2
Active, not recruiting NCT04439201 - Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B) Phase 2
Completed NCT04439240 - Testing AZD4547 as a Potential Targeted Treatment in Cancers With FGFR Genetic Changes (MATCH-Subprotocol W) Phase 2