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NCT00303797 · ClinicalTrials.gov registry record · Phase 1
Sorafenib and Bortezomib in Treating Patients With Advanced Cancer
A Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Refractory Multiple Myeloma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00303797: Completed Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Refractory Multiple Myeloma, sponsored by National Cancer Institute (NCI).
NCT00303797 is a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Refractory Multiple Myeloma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 500-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00303797, a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Refractory Multiple Myeloma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is studying the side effects and best dose of sorafenib and bortezomib in treating patients with advanced cancer. Sorafenib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of cancer cells by blocking blood flow to the cancer
Primary Outcome
DLTs include: Hematologic: Grade 4 ANC for ≥5 days, Grade 4 anemia of any duration, or PLT \<25,000 of any duration; Renal: Serum creatinine ≥2 times baseline or \> 2x upper limit of normal if baseline levels normal; All other non-hematologic toxicities ≥grade 3 as per CTCAE v3.0 except fatigue; Any toxicities that caused dose delay of \> 2 weeks of the intended next dose. MTD is the dose level below the lowest dose that induces DLT in at least one-third of patients (2 of 6 patients).
Conditions Studied
Interventions
- DRUG sorafenib tosylate
- DRUG 17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-12 |
| Phase | Phase 1 |
What the finished NCT00303797 record still lists
NCT00303797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 500-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (90% lower).
The record links to 5 conditions, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 2 interventions - of which sorafenib tosylate is the first listed.
NCT00303797 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00303797 about?
NCT00303797 is a clinical study titled "Sorafenib and Bortezomib in Treating Patients With Advanced Cancer". This phase I trial is studying the side effects and best dose of sorafenib and bortezomib in treating patients with advanced cancer. Sorafenib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of cancer cells...
What is the current status of trial NCT00303797?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2005-12.
What conditions does trial NCT00303797 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific, Refractory Multiple Myeloma, Refractory Chronic Lymphocytic Leukemia, Stage III Multiple Myeloma, Stage IV Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT00303797?
The interventions under investigation include: sorafenib tosylate (DRUG), 17-N-allylamino-17-demethoxygeldanamycin/bortezomib (DRUG).
Who is sponsoring clinical trial NCT00303797?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00303797 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unspecified Adult Solid Tumor, Protocol Specific
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 NCT00303797's enrollment target sits among peer trials
50 31st of 83 higher than 51 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific 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.
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