Dinaciclib in Treating Patients With Stage IV Melanoma : A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
PRIMARY OBJECTIVES:I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.SECONDARY OBJECTIVES:I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.OUTLINE: This is a multicenter study.Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.After completion of study treatment, patients are followed up every 6 months for up to 3 years..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 09. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: July 13, 2009, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 |
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| Study ID: |
NCT00937937 |
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| PPN (Katalog-ID): |
CTG000750409 |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: July 13, 2009, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 | ||
| 520 | |a PRIMARY OBJECTIVES:I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.SECONDARY OBJECTIVES:I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.OUTLINE: This is a multicenter study.Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.After completion of study treatment, patients are followed up every 6 months for up to 3 years. | ||
| 650 | 2 | |a Melanoma | |
| 650 | 2 | |a Hutchinson's Melanotic Freckle | |
| 650 | 2 | |a Lentigo | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Active, not recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
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