Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors

NCT02143401 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-11-22

No results posted yet for this study

Summary

This phase I trial studies the side effects and the best dose of navitoclax when given together with sorafenib tosylate in treating patients with solid tumors that have returned (relapsed) or do not respond to treatment (refractory). Navitoclax and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

  • Cirrhosis
  • Hepatitis B Infection
  • Hepatitis C Infection
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Hepatocellular Carcinoma
  • Recurrent Malignant Solid Neoplasm
  • Refractory Malignant Neoplasm
  • Stage IV Hepatocellular Carcinoma AJCC v7
  • Unresectable Solid Neoplasm

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Navitoclax

Given PO

OTHER

Pharmacological Study

Correlative studies

DRUG

Sorafenib

Given PO

DRUG

Sorafenib Tosylate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Brian A Costello · Mayo Clinic Cancer Center LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-30
Primary Completion
2022-11-30
Completion
2024-03-21

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02143401 on ClinicalTrials.gov