ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Advanced melanoma not responding to 1st line chemotherapy
- Histological evidence of melanoma
- Measurable disease according to RECIST criteria
- ECOG performance status less than or equal to 2
- Life expectancy 6 months or more
- Normal organ and bone marrow function as defined by hematological and serum chemistry limits
- Adequate contraception for females of childbearing potential
- Stage IV disease which has previously progressed during interferon treatment.
- Restriction of some therapies/medications for a certain timeframe prior to enrollment
and during the study including: investigational drugs, high dose corticosteroids,
immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong
QT interval and/or induce Torsades De Pointes
- History of uncontrolled seizure disorders
- Uncontrolled coagulation disorders.
- History or evidence of myocardial ischemia, congestive heart failure or arrythmias
requiring treatment in the past 6 months
- History of uncontrolled intercurrent or chronic illness
- Concurrent malignancies.
- Brain metastases.
- HIV positive.
- Prolonged QTc interval
- Uncontrolled intercurrent or chronic illnesses.
- Pregnant or lactating women
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Use of 852A in Metastatic Cutaneous Melanoma. | ||
| Official Title ICMJE | Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma. | ||
| Brief Summary | Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE |
| ||
| Intervention ICMJE | Drug: 852A | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 28 | ||
| Original Enrollment ICMJE | Same as current | ||
| Actual Study Completion Date ICMJE | August 2006 | ||
| Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | France, Germany, Switzerland | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00189332 | ||
| Other Study ID Numbers ICMJE | 1527-852A | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | October 2008 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||