Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors (NCT02143401) | Clinical Trial Compass
CompletedPhase 1
Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors
United States29 participantsStarted 2015-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* For Dose Escalation Cohort: Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* For Dose Expansion Cohort: HCC patients only: HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria; all of the following criteria must be met or a biopsy is required:
* Known cirrhosis or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Hypervascular liver masses \> 2 cm, and either serum alpha-fetoprotein (AFP) \> 400 ng/ml
* AFP \> three times normal and doubling in value in the antecedent 3 months
* In the expansion cohort, prior treatment with sorafenib as first-line therapy allowed
* Any number of the following prior therapies is allowed:
* Chemotherapy \>= 28 days prior to registration
* Mitomycin C/nitrosoureas \>= 42 days prior to registration
* Immunotherapy \>= 28 days prior to registration
* Biologic therapy \>= 28 days prior to registration
* Targeted therapy \>= 28 days prior to registration
* Radiation therapy \>= 28 days prior to registration
* Radiation to \< 25% of bone marrow
* HCC patients only: Prior regional treatments for liver metastasis are permitted including:
* Selective internal radiation therapy such as brachytherapy, cyber knife, radiolabeled microsphere embolization, etc.
* Hepatic artery chemoembolization
* Hepatic artery embolization
* H…