Unresectable Stage III or Stage IV MelanomaPhase 1/2NCT00412828
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
A Phase 1/2 study testing CR011-vcMMAE in people with Unresectable Stage III or Stage IV Melanoma, run by CuraGen Corporation at 4 sites in United States.
Trial summary
This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Stage III or Stage IV Melanoma
- What is being tested?
- CR011-vcMMAE
- Type of treatment
- Injection or infusion
- How many people
- 117 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2006to May 2011
- Phase
- Phase 1/2
- 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
- Male or female with age ≥ 18 years.
- Progressive or new metastatic melanoma, stage III or IV.
- Measurable disease by CT / MRI
- Failure of no more than 1 line of prior cytotoxic therapy.
- Adequate bone marrow, renal and hepatic function
- Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3
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- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- Total bilirubin ≤ 1.5 x upper normal limit (UNL)
- AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)
- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance > 45 mL/min/1.73 m2
- PT/aPTT < 1.5 x UNL or within therapeutic range via anti-coagulation therapy
- Karnofsky PS ≥ 70%.
- Estimated life expectancy > 3 months.
- Signed informed consent approved IRB and ability to comply with the study or monitoring procedures.
- Subjects with evaluable disease are eligible in dose-escalation cohorts
Who cannot join
- Prior therapies for disease under study less than 4 weeks prior to enrollment.
- Major surgery or trauma within 4 weeks of enrollment.
- Active brain metastases
- Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.
- History of allergic reactions to dolastatin, auristatin or compounds of similar composition.
- Significant cardiovascular disease
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- Other malignancies
- Pregnancy or breast feeding
- Refusal or inability to use effective means of contraception (for men, and women with childbearing potential)
- History of or test-positive to HIV, or hepatitis B or C
Trial locations and contacts
4 sites in 1 country.
United States4 sites
M.D. Anderson Cancer Center
Houston, Texas, 77030
Yale University
New Haven, Connecticut, 06520
New York University Medical Center
New York, New York, 10016
Angeles Clinic and Research Institute
Santa Monica, California, 90404
About this study
This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.
- Being tested
- CR011-vcMMAE
- Keywords
- Melanoma, CR011-vcMMAE
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR011-vcMMAEDrug
administered as an intravenous infusion of 250 mL over 90 min
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)
Measured: throughout the study
Secondary outcomes (3)
to evaluate the immune response to CR011-vcMMAE
Measured: throughout the study
to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE
Measured: throughout the study
to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Stage III or 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- CuraGen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412828
- Sponsor's protocol ID
- CR011-CLN-11
- Status last verified
- Feb 2015
- First submitted
- 18 Dec 2006
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ott PA, Hamid O, Pavlick AC, Kluger H, Kim KB, Boasberg PD, Simantov R, Crowley E, Green JA, Hawthorne T, Davis TA, Sznol M, Hwu P. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma. J Clin Oncol. 2014 Nov 10;32(32):3659-66. doi: 10.1200/JCO.2013.54.8115. Epub 2014 Sep 29.
PubMed 25267741
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00412828
- Acronym / sponsor ID
- CR011-CLN-11
- Keywords
- Melanoma, CR011-vcMMAE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- CuraGen CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Dec 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 study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female with age ≥ 18 years.
- Progressive or new metastatic melanoma, stage III or IV.
- Measurable disease by CT / MRI
- Failure of no more than 1 line of prior cytotoxic therapy.
- Adequate bone marrow, renal and hepatic function
Key exclusion criteria (10 listed)
- Prior therapies for disease under study less than 4 weeks prior to enrollment.
- Major surgery or trauma within 4 weeks of enrollment.
- Active brain metastases
- Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.
- History of allergic reactions to dolastatin, auristatin or compounds of similar composition.
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 |
|---|---|---|
| CR011-vcMMAEadministered as an intravenous infusion of 250 mL over 90 min | Drug | – |
Primary outcome
to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)
Time frame: throughout the study
3 secondary outcomes
to evaluate the immune response to CR011-vcMMAE
Time frame: throughout the study
to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE
Time frame: throughout the study
to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Results publication: PubMed 25267741Ott PA, Hamid O, Pavlick AC, Kluger H, Kim KB, Boasberg PD, Simantov R, Crowley E, Green JA, Hawthorne T, Davis TA, Sznol M, Hwu P. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma. J Clin Oncol. 2014 Nov 10;32(32):3659-66. doi: 10.1200/JCO.2013.54.8115. Epub 2014 Sep 29.
- Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma.Link provided by the sponsor.
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Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CR011-vcMMAE in people with Unresectable Stage III or Stage IV Melanoma, run by CuraGen Corporation at 4 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 15 inclusion and 10 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: finished, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412828, which also lists 1 linked publication.
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 19 Feb 2015.