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Pamiparib and Temozolomide for the Treatment of Hereditary Leiomyomatosis and Renal Cell Cancer

NCT04603365 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-17

No results posted yet for this study

Summary

This phase II trial investigates how well pamiparib and temozolomide work in treating patients with hereditary leiomyomatosis and renal cell (kidney) cancer. Poly adenosine diphosphate-ribose polymerase (PARPs) are proteins that help repair DNA mutations. PARP inhibitors, such as pamiparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pamiparib and temozolomide may help treat patients with hereditary leiomyomatosis and renal cell cancer.

Conditions

  • Clear Cell Papillary Renal Neoplasm
  • Collecting Duct Carcinoma
  • Hereditary Leiomyomatosis and Renal Cell Carcinoma
  • Hereditary Papillary Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Metastatic Unclassified Renal Cell Carcinoma
  • Papillary Renal Cell Carcinoma
  • Stage III Renal Cell Cancer American Joint Committee on Cancer (AJCC) v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Tubulocystic Renal Cell Carcinoma
  • Unresectable Renal Cell Carcinoma

Interventions

DRUG

Pamiparib

Given PO

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Driven To Cure

    collaborator UNKNOWN

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Brian Shuch, MD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2023-05-07
Completion
2023-05-07
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04603365 on ClinicalTrials.gov