A Study To Assess The Safety Of Administering CP-675,206 As A One Hour Infusion In Patients With Surgically Incurable Advanced Melanoma

June 5, 2012 updated by: AstraZeneca

A Phase 1, Open Label, Single Arm Study To Establish The Safety Of Administering CP 675,206 As A One Hour Infusion In Patients With Surgically Incurable Stage III Or Stage IV Melanoma

This will show if CP-675,206 can be administered safely as an intravenous infusion lasting one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study was prematurely discontinued on April 28, 2008 because a concomitant Phase 3 study met pre-specified futility criteria. The decision to close enrollment early was not based on any safety concerns.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • California
      • Los Angeles, California, United States, 90095
        • Research Site
      • Los Angeles, California, United States, 90095-7423
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed melanoma that is surgically incurable Note: Prior therapies for melanoma, including cancer vaccines, are permitted but are not required. There is no limit to the number of prior regimens for melanoma a patient may have received.
  • Evidence of at least one lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • CT scan of the brain with contrast or MRI of the brain within 6 weeks prior to enrollment showing no evidence of active brain metastases. PET scans and PET/CT scans are also acceptable.

Exclusion Criteria:

  • Previous treatment with other anti CTLA4 agents (eg, ipilimumab, MDX 010).
  • Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of CP 675,206 and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma.
  • History of chronic autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, etc.).
  • History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT scan only.
  • Brain metastases that have not been adequately treated with surgery or stereotactic radiosurgery and have not been stable at least 3 months prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: CP-675,206
15 mg/kg. IV (in the vein) over 1 hour on Day 1 of each 90 day cycle. Number of cycles: maximum of 4 cycles unless progression of disease or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess safety and tolerability during and for 1 hour following a 15 mg/kg dose of CP 675,206 administered as a one hour infusion.
Time Frame: Last patient dosed = 31Dec2009
Last patient dosed = 31Dec2009

Secondary Outcome Measures

Outcome Measure
Time Frame
To monitor for human anti human (HAHA) response to CP 675,206
Time Frame: Last HAHA time point obtain =estimated 31Dec2009
Last HAHA time point obtain =estimated 31Dec2009
To assess evidence of anti tumor activity as measured by best overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) criteria, duration of response, progression free survival
Time Frame: Last RECIST obtained = estimated 31Dec2009
Last RECIST obtained = estimated 31Dec2009
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of subjects treated with CP 675,206
Time Frame: Last PG obtained = estimated 31Dec2009
Last PG obtained = estimated 31Dec2009
To evaluate the overall safety and tolerability of CP 675,206 in this population
Time Frame: Last patient dosed = estimated 31Dec2009
Last patient dosed = estimated 31Dec2009
To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion
Time Frame: Last PK timepoint obtained =estiamted 31Dec2009
Last PK timepoint obtained =estiamted 31Dec2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3671022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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