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Bcl-2 Inhibitor
Navitoclax + Sorafenib for Cancer
Phase 1
Waitlist Available
Led By Brian A Costello
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Child Pugh class A or B7 liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial is testing navitoclax + sorafenib tosylate to see if it's safe and effective in treating patients with solid tumors.
Who is the study for?
This trial is for patients with solid tumors that are metastatic or unresectable and have not responded to standard treatments. Specifically, it includes those with hepatocellular carcinoma (HCC) who may have had prior sorafenib treatment. Participants must be in good physical condition, with adequate organ function and blood counts, no severe unresolved toxicity from previous therapies, no brain metastases or significant heart issues, and not on certain medications that could interact poorly with the trial drugs.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Navitoclax and Sorafenib Tosylate. It aims to find the safest dose while assessing how these drugs might stop tumor growth by inhibiting specific enzymes needed for cell proliferation. The study involves a phase I clinical trial which typically focuses on evaluating safety, tolerability, pharmacokinetics (how the drug moves through the body), and preliminary effectiveness.See study design
What are the potential side effects?
Potential side effects include risks associated with Navitoclax such as thrombocytopenia (low platelet count leading to bleeding risk), gastrointestinal symptoms, fatigue; Sorafenib may cause hypertension, hand-foot skin reactions among others. Both drugs can contribute to liver enzyme elevation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, and standard treatments have failed.
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My liver disease is mild to moderate.
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I can take care of myself but might not be able to do heavy physical work.
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I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD) of navitoclax
Secondary outcome measures
Time to progression
Time to treatment failure
Time until any treatment related toxicity
+3 moreOther outcome measures
Change in cleaved and total CK18 levels in serum
Changes in hepatoma Mcl-1 expression level in tumor tissue (expansion cohort only)
Changes in levels of cleaved cytokeratin 18 (expansion cohort only)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (navitoclax, sorafenib tosylate)Experimental Treatment5 Interventions
Patients receive navitoclax PO QD on days 1-21 (days 1-28 cycle of 1 only) and sorafenib tosylate PO BID on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib Tosylate
2005
Completed Phase 3
~4010
Navitoclax
2012
Completed Phase 2
~90
Sorafenib
2014
Completed Phase 3
~1670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,124 Total Patients Enrolled
17 Trials studying Liver Cirrhosis
11,754 Patients Enrolled for Liver Cirrhosis
Brian A CostelloPrincipal InvestigatorMayo Clinic Cancer Center LAO
1 Previous Clinical Trials
19 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not willing to use birth control.I haven't had bleeding due to low platelet count in the last year.I am currently taking blood thinners.My cancer is advanced, cannot be surgically removed, and standard treatments have failed.My liver cancer diagnosis was confirmed by a biopsy or through clinical and imaging tests.I have had previous treatments for my condition.My liver disease is mild to moderate.I can take care of myself but might not be able to do heavy physical work.I am HIV-positive and on effective treatment.I have no lasting side effects from cancer treatment, except for hair loss.I have cancer that has spread to my brain.I have a history of high blood pressure in the liver or bleeding from enlarged veins.My high blood pressure is not well-controlled.I am not taking any restricted medications.I have a condition that increases my risk of bleeding.I have had treatments specifically for liver cancer spread.I can swallow and keep down pills.I do not have any unmanaged ongoing illnesses.I have had heart disease within the last 6 months.I have been treated with sorafenib as my first cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (navitoclax, sorafenib tosylate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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