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NCT00597038 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Dasatinib and Dacarbazine
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00597038 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 50 participants.
The verdict
NCT00597038, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to: Phase I Objectives: * Find the most tolerated dose to use for Phase II * Collect information on how the body responds to this combination of study drug Phase II Objectives: * To determine the overall response of participants using this combination of study drug The expression of proto-oncogene tyrosine-protein kinase (Src), a substance present in a significant proportion of melanomas plays a role in the growth, multiplying, and dividing of cancer cells. Melanoma cells appear to be sensitive to these agents that block the action of Src in concentrations that can be achieved in patients. We suggest that Src inhibitors (such as Dasatinib) may be a good choice for treatment of melanoma in combination with Dacarbazine (a chemotherapy drug that can cause the shrinkage of melanomas). We wish to to evaluate the Src inhibitor Dasatinib in combination with the chemotherapy drug Dacarbazine. The novel oral Src inhibitor Dasatinib may be able to increase the effectiveness of chemotherapy for melanoma compared to chemotherapy alone. Dacarbazine is a standard treatment for melanoma currently. The effectiveness of this chemotherapy drug may be increased by combination with Dasatinib. Dacarbazine has been approved by the US Food and Drug Administration (FDA) for treating melanoma; Dasatinib has been approved by the FDA to treat leukemia, but it has not been approved alone or in combination with Dacarbazine to treat melanoma.
Interventions
- DRUG Dasatinib and Dacarbazine (DTIC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00597038
The ClinicalTrials.gov registry entry for NCT00597038 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dasatinib and Dacarbazine (DTIC) is the first listed.
NCT00597038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00597038 about?
NCT00597038 is a clinical study titled "A Phase I/II Study of Dasatinib and Dacarbazine". The purpose of this study is to: Phase I Objectives: * Find the most tolerated dose to use for Phase II * Collect information on how the body responds to this combination of study drug Phase II Objectives: * To determine the overall response of participants using this combination of study drug ...
What is the current status of trial NCT00597038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2007-11. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00597038?
The interventions under investigation include: Dasatinib and Dacarbazine (DTIC) (DRUG).
Who is sponsoring clinical trial NCT00597038?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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