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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.