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NCT00923169 · ClinicalTrials.gov registry record · Phase 1
Part 2 of Phase 1 Study of GC1008 to Treat Advanced Melanoma (Part 2 Will Only Accept and Treat Patients With Advanced Malignant Melanoma)
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00923169: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923169 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923169, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: * GC1008 is a genetically engineered antibody designed to block the activity of transforming growth factor-beta (TGF-beta). Although TGF-beta has some normal and beneficial effects in the body, it is often over-produced in malignant melanoma tumors, and it can help the melanoma grow and spread. * Part 1 of this study enrolled 22 subjects with malignant melanoma or kidney cancer to determine the highest safe dose of GC1008, which was found to be 15 mg/kg. * Three of 22 patients with malignant melanoma in Part 1 of the study developed skin problems, but it is not known if these problems were related to the administration of GC1008. Objectives: -To determine the frequency of adverse skin side effects of GC1008 in patients with malignant melanoma. Eligibility: -Patients 18 years of age and older with malignant melanoma for whom previous treatment was not successful. Design: * GC1008 is given intravenously (through a vein) at a dose of 15 mg/kg or 10 mg/kg for four doses on study days 0, 28, 42 and 56 (one treatment cycle). Patients whose cancer responds to GC1008 may receive one or two additional treatment cycles of four doses given every two weeks. * Physical exam and vital signs on study days 1, 14, 28, 42, 56, 84 and 140. * Vitals signs on study days 0, 14, 28, 42, 56, 84 and 140. * Frequent blood sample collections for routine safety tests, measurement of blood levels of GC1008, analysis for antibodies against GC1008 and for research studies. * CT or MRI scan, bone scan and PET CT scan before treatment and on study day 84 and 140. * Biopsy of apparently normal skin before treatment and again on day 84. * Review of medicines and well being on study days 0, 14, 28, 42, 56, 84, 112 and 140. * Follow-up visits every 3 months for up 2 years for patients who have not received additional treatment for their cancer. Evaluations include physical exam, CT or MRI scan, PET CT scan, blood tests and possibly tumor biopsies.
Interventions
- DRUG Anti-Transforming Growth Factor-beta (GC 1008)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-07-09 |
| Est. Completion | 2010-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923169
The ClinicalTrials.gov registry entry for NCT00923169 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anti-Transforming Growth Factor-beta (GC 1008) is the first listed.
NCT00923169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923169 about?
NCT00923169 is a clinical study titled "Part 2 of Phase 1 Study of GC1008 to Treat Advanced Melanoma (Part 2 Will Only Accept and Treat Patients With Advanced Malignant Melanoma)". Background: * GC1008 is a genetically engineered antibody designed to block the activity of transforming growth factor-beta (TGF-beta). Although TGF-beta has some normal and beneficial effects in the body, it is often over-produced in malignant melanoma tumors, and it can help the melanoma grow and...
What is the current status of trial NCT00923169?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2006-07-09. Estimated completion is 2010-01-20.
What interventions are being tested in trial NCT00923169?
The interventions under investigation include: Anti-Transforming Growth Factor-beta (GC 1008) (DRUG).
Who is sponsoring clinical trial NCT00923169?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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