New drug combo targets Hard-to-Treat cancers in early trial
NCT ID NCT01303341
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This early-phase trial tested the safety and best dose of two drugs—riluzole and sorafenib—given together to people with advanced solid tumors or melanoma that had spread and stopped responding to standard treatments. The goal was to find the highest safe dose and see if the combination could slow tumor growth. A total of 35 participants were enrolled.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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35 people
The number who actually took part.
- Started
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Feb 2011
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically proven solid tumors (Phase I) with biopsiable tumor (expansion cohort) refractory to standard therapy or for whom no standard therapy exists or who decline standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Patients must be willing and able to sign informed consent * Unlimited prior therapies are permitted for patients enrolled in the dose escalation phase of the study; patients in the expansion cohort of the study may not have any prior therapy with riluzole or sorafenib and must have biopsiable tumor * Patients may have measurable or evaluable disease * Absolute neutrophil count (ANC) \>= 1,500/uL * Platelets \>= 100,000/uL * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN * International normalized ratio (INR) =\< 1.5 x institutional ULN * Creatinine =\< 2 x ULN * Patients with brain lesions that have been treated with whole brain radiotherapy and are clinically stable for at least 4 weeks, are not taking steroids and are not receiving enzyme-inducing anticonvulsants will be eligible Exclusion Criteria: * Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator * For patients who have received gamma knife or stereotactic radiosurgery, a 2 week washout is required; patients who have had other types of radiotherapy, chemotherapy or biologic agents within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier to =\< grade 1; at least 4 weeks must have elapsed since any major surgery; patients with prostate cancer may continue to receive hormonal therapy * History of allergic reactions attributed to riluzole or sorafenib * Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 2 weeks after discontinuation of riluzole and/or sorafenib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; pregnant (positive pregnancy test) or lactating patients cannot participate * Known human immunodeficiency virus (HIV) infection or known history of active hepatitis B or C infection * Current, recent (within 4 weeks of the first treatment of this study), or planned participation in an experimental drug study (prevention trials are permitted if the trial is not testing a novel experimental agent) * Cardiac disease: congestive heart failure \> class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months * History of stroke within six months * Clinically significant peripheral vascular disease * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Uncontrolled hypertension, defined as systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 90 mm Hg, despite optimal medical management * Active clinically serious infection \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2 * Any of the following within 6 months prior to first dose of treatment: myocardial infarction, symptomatic coronary artery disease (severe or unstable angina), artery bypass graft, uncontrolled arrhythmias, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolus * Pulmonary hemorrhage/bleeding event \>= CTCAE grade 2 within 4 weeks of first-dose of study drug * Any other hemorrhage/bleeding event \>= CTCAE grade 3 within 4 weeks of first dose of study drug * Evidence or history of bleeding diathesis or coagulopathy * Major surgery or significant traumatic injury within 4 weeks of first study drug * The eligibility of patients taking medications that are potent modulators of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6), subfamily 2, polypeptide 8 (2C8) will be determined following a review of their case by the principal investigator; every effort should be made to switch patients taking such agents or substances to other medications * Any condition that impairs the patient's ability to swallow whole pills * Any malabsorption problem * Anticipation of need for major surgical procedure during the course of the study * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of treatment * Serious, non-healing wound, ulcer, or bone fracture * Inability to comply with study and/or follow-up procedures * Anticoagulation with Lovenox (enoxaparin) is permitted, however, patients on anticoagulation with warfarin are not permitted on this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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Other studies related to the condition(s) this trial covers.
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