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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: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/\< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despit
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 |
What the finished NCT00597038 record still lists
NCT00597038 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which Dasatinib and Dacarbazine (DTIC) is the first listed.
NCT00597038 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00597038's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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