CP-675,206 In Patients With Advanced Melanoma

Malignant Melanoma Clinical Trial

Official title:

Phase 1 Open Label, Non-Randomized, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Immune Function Effects, And Efficacy Of Multiple Doses Of CP-675,206 In Patients With Advanced Melanoma, And Phase 2, Open Label, Randomized Study To Evaluate the Efficacy, Safety, Tolerability And Pharmacokinetics Of 2 Regimens Of CP-675,206 In Patients With Advanced Melanoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086489
• Other study ID #: A3671002
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2004
• Last updated: June 5, 2012
• Start date: August 2003
• Est. completion date: May 2009

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

The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed: Stage III (AJCC 6th edition)xxl unresectable melanoma, with measurable disease (either locally relapsed unresectable, in-transit lesions or unresectable draining nodes) or Stage IV melanoma, including:

• Metastasis to skin, subcutaneous tissues or distant lymph nodes, or

• Metastasis to lungs, or

• Metastasis to all other visceral sites with either LDH <= ULN (upper limit of normal) or a single site of metastasis

• Note: Patients with melanoma of ocular origin will be considered ineligible

• Documented progressive disease following adjuvant therapy, localized therapy or other therapy for metastatic disease

• Measurable disease defined by at least one target lesion that can be accurately measured and whose size is at least 1.0 cm (by spiral CT) or 2.0 cm (by conventional techniques) in its longest diameter

• ECOG performance status of 0 or 1 Life expectancy of > 3 months

• Either gender, aged 18 years and above

• Adequate bone marrow, hepatic, and renal functions determined within 2 weeks prior to starting therapy, defined as:

• Absolute neutrophil count >= 1.5 x 10(9)cells/L

• Platelets >= 100 x 10(9)/L

• Hemoglobin >= 10 g/dL

• Aspartate and alanine aminotransferases (AST, ALT) <= 2.5 x ULN (<= 5 x ULN, if documented liver metastases are present)

• Total bilirubin <= 1.5 x ULN

• Creatinine <= 1.5 x ULN

• Patients must have recovered from all prior treatment related toxicities, to baseline status, or a CTC grade of 0 or 1. Post-surgical pain shall not be considered a basis for exclusion.

• Females must either be not of childbearing potential [surgically sterilized, which includes tubal ligation, or at least 2 years postmenopausal; not breastfeeding], or practicing 1 form of approved contraception for at least three months prior to entry into the study with 1 of the following methods: (a) oral contraceptives, (b) intrauterine device, (c) implanted contraceptive (such as Norplant®), (d) injected contraceptives (such as Depo-Provera®), (e) diaphragm, (f) sexual partner must use condom or be surgically sterilized, or (g) sexually inactive. Females of childbearing potential must be instructed to avoid pregnancy during study participation. Negative serum or urine pregnancy test must be documented during screening evaluation.

• Must be willing and able to provide written informed consent.

Exclusion Criteria:

• Received immunotherapy for cancer within one month prior to the start of screening

• Patients previously treated on this protocol

• History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (e.g. Addison's disease, asthma, celiac disease, multiple sclerosis, Graves Disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc.)

• Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history.

• History of autoimmune colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.

• Pregnant or lactating women.

• Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.

• Diagnosed or suspected brain metastases. Patients with past history of brain metastases but with no radiologic evidence within 12 weeks prior to enter into the protocol will be eligible.

• Any serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment.

• Coexisting malignancies except for basal or squamous cell carcinoma of the skin.

• Received any prior CTLA4 inhibiting agent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• CP-675,206
pts treated at 10 mg/kg dose level on a monthly regimen
• CP-675,206
pts treated at 15 mg/kg dose level on a quarterly regimen

Locations

Country	Name	City	State
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Chicago	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	Nashville	Tennessee
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		At every scheduled visit for a maximum of 2 years from first dose of study drug	No
Primary	Tumor response		Assessed every 2-3 months up to 2 years from first dose of study drug	No
Secondary	Monitor for human anti-human antibodies at the end of the study		Pre-dose (Cycle 1 only) and end of study	No
Secondary	Explore genetic influences on safety and or immune response		Pre-dose, Cycle 1	No
Secondary	Assess PK during treatment		All cycles as pre-specified in protocol	No