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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00369395 |
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Date of registration:
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24/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Volociximab in Metastatic Melanoma
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Scientific title:
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A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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19 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00369395 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Mihail Obrocea, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Must give written informed consent and any authorizations required by local law
(e.g., Protected Health Information [PHI]).
2. Aged >=18 years old at the time of informed consent.
3. Stage III and Stage IV unresectable melanoma with documented progression during or
following the most recent prior melanoma therapy.
4. Must have failed at least 1 prior therapy for metastatic disease.
5. Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely
accessible for pre treatment and post treatment biopsies.
6. Must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in
Stage 1 only).
7. Must have at least 1 measurable target lesion for CT/MRI assessment, according to
RECIST criteria.
8. ECOG Performance Status <=1.
9. Acceptable laboratory results
10. Life expectancy >=12 weeks.
11. Male subjects and female subjects of child bearing potential must be willing to
practice effective contraception during the study and be willing and able to continue
contraception for 4 months after last infusion of study treatment.
Exclusion Criteria
1. Subjects with any other active malignancy in addition to metastatic melanoma.
2. CNS metastases, unless stable for at least 2 months following definitive local
therapy (surgery, stereotactic radiation). Subjects may not require treatment with
steroids or anticonvulsants.
3. History of any other significant medical condition, including cardiovascular,
pulmonary, neurologic, or autoimmune disease; active infections (e.g., bacterial or
fungal); or a psychiatric condition within 6 months of Day 1
4. History of hepatitis B or C.
5. Known history of HIV infection or AIDS.
6. History of thromboembolic or cerebrovascular events, such as stroke, transient
ischemic attack, deep vein thrombosis, or bleeding disorders within 12 months prior
to Day 1.
7. Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for
melanoma within 4 weeks prior to Day 1.
8. Previous exposure to volociximab.
9. Aspirin, high dose warfarin, or heparin use. (Note: Aspirin <=81 mg/day, low-dose
warfarin 1 mg/day or low-dose heparin for IV catheter patency is allowed.)
10. Major surgery within 4 weeks prior to Day 1.
11. Requirement for immunosuppression, and/or systemic steroid therapy.
12. Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior
investigational drug (whichever is longer).
13. Known hypersensitivity to murine or chimeric antibodies.
14. Any condition that, in the opinion of the Investigator, makes the subject unsuitable
for study participation.
15. Female subjects who are pregnant or currently breastfeeding.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stage IV Melanoma
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Intervention(s)
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Drug: volociximab
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Primary Outcome(s)
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Progression Free Survival (PFS) rate at the Week 8 visit, defined as the number of subjects who have not progressed by the Week 8 visit
[Time Frame: 8 weeks intervals]
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Secondary Outcome(s)
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Pharmacokinetics of volociximab
[Time Frame: Every infusion and follow up visit]
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Assess safety by recording and evaluating adverse events (AEs); changes in vital signs, hematology, blood chemistry, and urinalysis parameters; and anti-volociximab antibody formation
[Time Frame: Throught study and follow up period,approx. 15 months]
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Secondary ID(s)
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206-MM-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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