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NCT01303341 · ClinicalTrials.gov registry record · Phase 1
Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma
A Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01303341: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT01303341 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01303341, a Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of sorafenib tosylate when given together with riluzole in treating patients with solid tumors or melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Riluzole may stop or slow the growth of tumor cells. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving riluzole together with sorafenib tosylate may kill more tumor cells.
Primary Outcome
Maximum tolerated dose is defined as the first dose level at which exactly 2/6 patients experience dose limiting toxicity, or at which 1/6 experience dose limiting toxicity and (due to de-escalation) at least 2/3 or 3/6 patients treated with the next higher dose level had dose limiting toxicity.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Riluzole
- OTHER Pharmacological Study
- DRUG Sorafenib Tosylate
Study Locations (1)
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2011-02-18 |
| Est. Completion | 2026-09-17 |
| Phase | Phase 1 |
What the registry record for NCT01303341 still lists
NCT01303341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (80% lower).
The record links to 8 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01303341 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01303341 about?
NCT01303341 is a clinical study titled "Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma". This phase I trial studies the side effects and best dose of sorafenib tosylate when given together with riluzole in treating patients with solid tumors or melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Riluzole may stop or slow the gro...
What is the current status of trial NCT01303341?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2011-02-18. Estimated completion is 2026-09-17.
What conditions does trial NCT01303341 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Recurrent Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT01303341?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Riluzole (DRUG), Pharmacological Study (OTHER), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT01303341?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01303341 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01303341's enrollment target sits among peer trials
35 71st of 108 higher than 23 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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