At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
cediranib maleatedrug
Likely dose
Cediranib (AZD2171) given orally at dose to be determinedAI-extracted
Key inclusion· 6
- ✓Histologically or cytologically confirmed recurrent or metastatic malignant melanoma (stage IV acral lentiginous, lentigo maligna, superficial spreading, or ocular subtypes)
- ✓At least 1 measurable lesion ≥20 mm (longest diameter) on conventional imaging or ≥10 mm on spiral CT
- ✓No prior chemotherapy for metastatic/recurrent disease; prior adjuvant immunotherapy permitted if completed >3 months before entry; prior radiation ≥4 weeks before entry acceptable; prior surgery ≥4 weeks before entry acceptable
- ✓Life expectancy >12 weeks
Key exclusion· 11
- ✕Prior chemotherapy or immunotherapy for recurrent/metastatic disease
- ✕Brain metastases
- ✕History of allergic reactions to compounds of similar chemical or biologic composition to AZD2171
- ✕QTc >470 msec (Bazett's correction) on screening ECG or history of familial long QT syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of AZD2171 in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
In Brief
A Phase 2 clinical trial evaluating cediranib maleate for Acral Lentiginous Malignant Melanoma and 10 related conditions. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This phase II trial is studying how well AZD2171 works in treating patients with recurrent or stage IV melanoma. AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcral Lentiginous Malignant Melanoma, Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Extraocular Extension Melanoma, Intraocular Melanoma, Iris Melanoma, Lentigo Maligna Malignant Melanoma, Recurrent Melanoma, Stage, Intraocular Melanoma, Stage IV Melanoma, Superficial Spreading Malignant Melanoma
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2005
Enrollment StartJan 2006
Primary CompletionMar 2012
TodayJul 2026
First PostedOct 21, 2005
Enrollment StartJan 1, 2006
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 20.7 years ago
Interventions
cediranib maleatedrug
Given orally