Stage IV MelanomaPhase 2NCT00369395
A Study of Volociximab in Metastatic Melanoma
A Phase 2 study testing volociximab in people with Stage IV Melanoma, run by Abbott at 7 sites in United States.
Trial summary
This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma. The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Melanoma
- What is being tested?
- volociximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
- Aged >=18 years old at the time of informed consent.
- Stage III and Stage IV unresectable melanoma with documented progression during or following the most recent prior melanoma therapy.
- Must have failed at least 1 prior therapy for metastatic disease.
- Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely accessible for pre treatment and post treatment biopsies.
- Must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in Stage 1 only).
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- Must have at least 1 measurable target lesion for CT/MRI assessment, according to RECIST criteria.
- ECOG Performance Status <=1.
- Acceptable laboratory results
- Life expectancy >=12 weeks.
- 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.
Who cannot join
- Subjects with any other active malignancy in addition to metastatic melanoma.
- 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.
- 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
- History of hepatitis B or C.
- Known history of HIV infection or AIDS.
- 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.
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- Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for melanoma within 4 weeks prior to Day 1.
- Previous exposure to volociximab.
- 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.)
- Major surgery within 4 weeks prior to Day 1.
- Requirement for immunosuppression, and/or systemic steroid therapy.
- Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior investigational drug (whichever is longer).
- Known hypersensitivity to murine or chimeric antibodies.
- Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
- Female subjects who are pregnant or currently breastfeeding.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Site Reference ID/Investigator# 70375
Aurora, Colorado, 80045
Site Reference ID/Investigator# 70376
Boston, Massachusetts, 02115
Site Reference ID/Investigator# 70377
Dallas, Texas, 75246
Site Reference ID/Investigator# 70380
Greenville, South Carolina, 29605
Site Reference ID/Investigator# 70356
La Jolla, California, 92093
Site Reference ID/Investigator# 70357
Scottsdale, Arizona, 85258
Site Reference ID/Investigator# 70359
St Louis, Missouri, 63110
About this study
Official title: A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma
This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma.
The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated.
- Conditions
- Stage IV Melanoma
- Being tested
- volociximab
- Keywords
- melanoma, antibody, angiogenesis, volociximab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volociximabDrug
Volociximab, 15 mg/kg, IV infusion once a week for 8 weeks. Subjects who achieved SD or better at Day 50 ± 2 days (Week 8) were eligible to continue receiving weekly infusions of volociximab until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Volociximab | Experimental | Volociximab 15 mg/kg Receives: Drug: volociximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks intervals
Secondary outcomes (2)
Pharmacokinetics of volociximab
Measured: Every infusion and follow up visit
Assess safety by recording and evaluating adverse events (AEs); changes in vital signs, hematology, blood chemistry, and urinalysis parameters; and anti-volociximab antibody formation
Measured: Throught study and follow up period,approx. 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Insufficient clinical activity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Mihail Obrocea, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369395
- Sponsor's protocol ID
- 206-MM-201
- Status last verified
- Apr 2012
- First submitted
- 24 Aug 2006
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00369395
- Acronym / sponsor ID
- 206-MM-201
- Conditions
- Stage IV Melanoma
- Keywords
- melanoma, antibody, angiogenesis, volociximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient clinical activity
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Dec 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma.
The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volociximab | Experimental | Drug: volociximabVolociximab 15 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
- Aged >=18 years old at the time of informed consent.
- Stage III and Stage IV unresectable melanoma with documented progression during or following the most recent prior melanoma therapy.
- Must have failed at least 1 prior therapy for metastatic disease.
- Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely accessible for pre treatment and post treatment biopsies.
Key exclusion criteria (15 listed)
- Subjects with any other active malignancy in addition to metastatic melanoma.
- 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.
- 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
- History of hepatitis B or C.
- Known history of HIV infection or AIDS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volociximabVolociximab, 15 mg/kg, IV infusion once a week for 8 weeks. Subjects who achieved SD or better at Day 50 ± 2 days (Week 8) were eligible to continue receiving weekly infusions of volociximab until disease progression. | Drug | Volociximab |
Primary outcome
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
2 secondary outcomes
Pharmacokinetics of volociximab
Time frame: Every infusion and follow up visit
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
Results and safety
The study was stopped early (reason given: Insufficient clinical activity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihail Obrocea, MD study director
Abbott
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing volociximab in people with Stage IV Melanoma, run by Abbott at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient clinical activity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 8 weeks intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.