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

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT00585000

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: CP-675,206	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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. [Last patient dosed = 31Dec2009]

Secondary Outcome Measures

To monitor for human anti human (HAHA) response to CP 675,206 [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 [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 [Last PG obtained = estimated 31Dec2009]
To evaluate the overall safety and tolerability of CP 675,206 in this population [Last patient dosed = estimated 31Dec2009]
To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion [Last PK timepoint obtained =estiamted 31Dec2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Scottsdale	Arizona	United States	85258
2	Research Site	Los Angeles	California	United States	90095-7423
3	Research Site	Los Angeles	California	United States	90095
4	Research Site	Aurora	Colorado	United States	80045
5	Research Site	Atlanta	Georgia	United States	30322
6	Research Site	Indianapolis	Indiana	United States	46202
7	Research Site	Louisville	Kentucky	United States	40202
8	Research Site	Durham	North Carolina	United States	27710

Sponsors and Collaborators

AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00585000

Other Study ID Numbers:

A3671022

First Posted:

Jan 2, 2008

Last Update Posted:

Jun 6, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Melanoma

Tremelimumab

Study Results

No Results Posted as of Jun 6, 2012