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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

Must not have

Women of childbearing potential unwilling to employ adequate contraception

Current use of anticoagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing navitoclax and sorafenib tosylate in patients whose solid tumors have returned or don't respond to treatment. The drugs aim to stop cancer growth by blocking essential enzymes. Sorafenib has shown effectiveness in several cancers. The study will determine the best dose and monitor side effects.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not willing to use birth control.

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I am currently taking blood thinners.

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I am HIV-positive and on effective treatment.

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I have no lasting side effects from cancer treatment, except for hair loss.

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I have cancer that has spread to my brain.

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I have a history of high blood pressure in the liver or bleeding from enlarged veins.

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My high blood pressure is not well-controlled.

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I have a condition that increases my risk of bleeding.

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I do not have any unmanaged ongoing illnesses.

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I have had heart disease within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum tolerated dose (MTD) of navitoclax

Secondary study objectives

Time to progression

Time to treatment failure

Time until any treatment related toxicity

+3 more

Other study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~120