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
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
-
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
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