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Breast CancerPhase 1/2NCT00704158

Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer

A Phase 1/2 study testing CR011-vcMMAE in people with Breast Cancer, run by CuraGen Corporation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
CR011-vcMMAE
Type of treatment
Injection or infusion
How many people
42 participants
Where
5 sitesUnited States
Study dates
Jun 2008to Jun 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Females with confirmed breast cancer
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
  • Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:
  • At least one regimen must have been for locally advanced or metastatic disease
  • Subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
  • Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
  • Subjects with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
  • Documented progressive disease within 6 months of the last regimen
  • Adequate bone marrow, renal and liver function
  • Signed informed consent

Main Exclusion Criteria:

  • Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
  • Neuropathy > NCI-CTCAE Grade 1
  • Active brain metastases.
  • New York Heart Association class III or IV heart disease
  • Unstable angina
  • Uncontrolled arrhythmia
  • A marked baseline prolongation of QT/QTc interval
  • Pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30341

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Hematology Oncology Associates

    Lake Worth, Florida, 33461

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Cornell University

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer

This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.

Conditions
Breast Cancer
Being tested
CR011-vcMMAE
Keywords
CR011-vcMMAE, locally advanced breast cancer, metastatic breast cancer, breast cancer, CuraGen
Medical subject headings
Breast Neoplasms

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 on Day 1 of a 21 day cycle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients

    Measured: throughout the study

  2. To determine the MTD of CR011-vcMMAE in breast cancer patients

    Measured: throughout the study

Secondary outcomes (1)

  1. Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression)

    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.

  1. First posted24 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionNov 2010
  4. Study completionJun 2011

Resources

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704158
Sponsor's protocol ID
CR011-CLN-20
Status last verified
Feb 2015
First submitted
23 Jun 2008
Last updated
19 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bendell J, Saleh M, Rose AA, Siegel PM, Hart L, Sirpal S, Jones S, Green J, Crowley E, Simantov R, Keler T, Davis T, Vahdat L. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with locally advanced or metastatic breast cancer. J Clin Oncol. 2014 Nov 10;32(32):3619-25. doi: 10.1200/JCO.2013.52.5683. Epub 2014 Sep 29.

    PubMed 25267761

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CR011-vcMMAE in people with Breast Cancer, run by CuraGen Corporation at 5 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?

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 5 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 safety and tolerability of CR011-vcMMAE in breast cancer patients (time frame: throughout the study). The study lists 2 primary outcomes in all. 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 NCT00704158, 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.

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