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A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IV Melanoma

Thank you

Trial Information

A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

8 weeks intervals

Safety Issue:

No

Principal Investigator

Mihail Obrocea, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

206-MM-201

NCT ID:

NCT00369395

Start Date:

December 2006

Completion Date:

March 2008

Related Keywords:

  • Stage IV Melanoma
  • melanoma
  • antibody
  • angiogenesis
  • volociximab
  • Melanoma

Name

Location

Site Reference ID/Investigator# 70357Scottsdale, Arizona  85258
Site Reference ID/Investigator# 70356La Jolla, California  92093
Site Reference ID/Investigator# 70375Aurora, Colorado  80045
Site Reference ID/Investigator# 70376Boston, Massachusetts  02115
Site Reference ID/Investigator# 70359St. Louis, Missouri  63110
Site Reference ID/Investigator# 70380Greenville, South Carolina  29605
Site Reference ID/Investigator# 70377Dallas, Texas  75246