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CP-675,206 In Patients With Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00086489
Recruitment Status : Completed
First Posted : July 5, 2004
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE July 1, 2004
First Posted Date  ICMJE July 5, 2004
Last Update Posted Date June 6, 2012
Study Start Date  ICMJE August 2003
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2008)
  • Safety [ Time Frame: At every scheduled visit for a maximum of 2 years from first dose of study drug ]
  • Tumor response [ Time Frame: Assessed every 2-3 months up to 2 years from first dose of study drug ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
  • Monitor for human anti-human antibodies at the end of the study [ Time Frame: Pre-dose (Cycle 1 only) and end of study ]
  • Explore genetic influences on safety and or immune response [ Time Frame: Pre-dose, Cycle 1 ]
  • Assess PK during treatment [ Time Frame: All cycles as pre-specified in protocol ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CP-675,206 In Patients With Advanced Melanoma
Official Title  ICMJE 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.
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Melanoma
Intervention  ICMJE
  • Drug: CP-675,206
    pts treated at 10 mg/kg dose level on a monthly regimen
  • Drug: CP-675,206
    pts treated at 15 mg/kg dose level on a quarterly regimen
Study Arms  ICMJE
  • Experimental: 10 mg/kg
    pts treated at 10 mg/kg dose level on a monthly regimen
    Intervention: Drug: CP-675,206
  • Experimental: 15 mg/kg
    pts treated at 15 mg/kg dose level on a quarterly regimen
    Intervention: Drug: CP-675,206
Publications * Comin-Anduix B, Lee Y, Jalil J, Algazi A, de la Rocha P, Camacho LH, Bozon VA, Bulanhagui CA, Seja E, Villanueva A, Straatsma BR, Gualberto A, Economou JS, Glaspy JA, Gomez-Navarro J, Ribas A. Detailed analysis of immunologic effects of the cytotoxic T lymphocyte-associated antigen 4-blocking monoclonal antibody tremelimumab in peripheral blood of patients with melanoma. J Transl Med. 2008 May 1;6:22. doi: 10.1186/1479-5876-6-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2011)
118
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00086489
Other Study ID Numbers  ICMJE A3671002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP