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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00585000
• Other study ID #: A3671022
• Status: Terminated
• Phase: Phase 1
• First received: December 21, 2007
• Last updated: June 5, 2012
• Start date: December 2007
• Est. completion date: January 2010

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Durham	North Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To monitor for human anti human (HAHA) response to CP 675,206		Last HAHA time point obtain =estimated 31Dec2009	No
Secondary	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	No
Secondary	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	No
Secondary	To evaluate the overall safety and tolerability of CP 675,206 in this population		Last patient dosed = estimated 31Dec2009	No
Secondary	To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion		Last PK timepoint obtained =estiamted 31Dec2009	No