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A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Pfizer
Sponsor:
Collaborator:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02444793
First received: May 12, 2015
Last updated: December 2, 2016
Last verified: December 2016
  Purpose
This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.

Condition Intervention Phase
Advanced/Metastatic Solid Tumors
Drug: PF-05082566
Drug: KW-0761
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Study Of Pf-05082566 In Combination With Mogamulizumab (Kw-0761) In Patients With Advanced Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participant with Dose-Limiting Toxicities (DLTs) [ Time Frame: First 2 cycles of treatment ] [ Designated as safety issue: Yes ]
    DLTs of PF-05082566 in combination with KW-0761 occurred during the first 2 treatment cycles


Secondary Outcome Measures:
  • Maximum serum concentration (Cmax) of PF-05082566 [ Time Frame: Cycles 1 - 5 up to 5 months ] [ Designated as safety issue: No ]
    Cmax is defined as the maximum serum concentration of PF-05082566

  • Maximum serum concentration (Cmax) of KW-0761 [ Time Frame: Cycles 1 & 5, up to 5 months ] [ Designated as safety issue: No ]
    Cmax is defined as the maximum serum concentration of KW-0761

  • Time to reach the maximum serum concentration (Tmax) of PF-05082566 [ Time Frame: Cycles 1 - 5, up to 5 months ] [ Designated as safety issue: No ]
    Tmax is the time needed from the start of infusion, to reach the maximum serum concentration of PF-05082566

  • Time to reach the maximum serum concentration (Tmax) of KW-0761 [ Time Frame: Cycles 1 & 5, up to 5 months ] [ Designated as safety issue: No ]
    Tmax is the time needed from the start of infusion, to reach the maximum serum concentration of KW-0761

  • Trough serum concentration (Ctrough) of PF-05082566 [ Time Frame: Cycles 1 - 5, 8, 12, 16, 20, 24 up to 24 months ] [ Designated as safety issue: No ]
    Ctrough is defined as the concentration at the end of PF-05082566 dosage interval

  • Trough serum concentration (Ctrough) of KW-0761 [ Time Frame: Cycles 1 - 5, 8, 12, 16, 20, 24 up to 24 months ] [ Designated as safety issue: No ]
    Ctrough is defined as the concentration at the end of KW-0761 dosage interval

  • Area Under the Curve0-last (AUC0-last) of PF-05082566 [ Time Frame: Cycle 5 up to 5 months ] [ Designated as safety issue: No ]
    AUC0-last is the area under the curve from time 0 to last measurable concentration of PF-05082566

  • Area Under the Curve0-last (AUC0-last) of KW-0761 [ Time Frame: Cycle 5 up to 5 months ] [ Designated as safety issue: No ]
    AUC0-last is the area under the curve from time 0 to last measurable concentration of KW-0761

  • Area Under the Curve 0-tau (AUC0-tau) of PF-05082566 [ Time Frame: Cycle 5, up to 5 months ] [ Designated as safety issue: No ]
    AUC0-tau is the area under the concentration curve over the dosing interval of PF-05082566

  • Area Under the Curve0-tau (AUC0-tau) of KW-0761 [ Time Frame: Cycle 5, up to 5 months ] [ Designated as safety issue: No ]
    AUC0-tau is the area under the concentration curve over the dosing interval of KW-0761

  • Elimination half life (t½) of PF-05082566 [ Time Frame: Cycle 5, up to 5 months ] [ Designated as safety issue: No ]
    t1/2 is defined as the time required for the concentration of PF-05082566 to reach half of its original value.

  • Elimination half life (t½) of KW-0761 [ Time Frame: Cycle 5 up to 5 months ] [ Designated as safety issue: No ]
    t1/2 is defined as the time required for the concentration of KW-0761 to reach half of its original value.

  • Volume of distribution at a steady state (Vss) of PF-05082566 [ Time Frame: Cycle 5, up to 5 months ] [ Designated as safety issue: No ]
    Vss is defined as the actual blood and tissue volume into which PF-05082566 is distribute and the relative binding of drug to protein in this spaces.

  • Volume of distribution at a steady state (Vss) of KW-0761 [ Time Frame: Cycle 5, up to 5 months ] [ Designated as safety issue: No ]
    Vss is defined as the actual blood and tissue volume into which KW-0761 is distribute and the relative binding of drug to protein in this spaces.

  • Clearance (CL) of PF-05082566 [ Time Frame: Cycle 5, up to 5 months ] [ Designated as safety issue: No ]
    Clearance (CL) is defined as the volume of blood from which PF-05082566 can be completely removed per unit of time

  • Clearance (CL) of KW-0761 [ Time Frame: Cycle 5, up to 5 months ] [ Designated as safety issue: No ]
    Clearance (CL) is defined as the volume of blood from which KW-0761 can be completely removed per unit of time

  • Anti-Drug Antibody (ADA) levels of PF-05082566/Neutralizing antibodies (Nab) titers for PF-05082566 [ Time Frame: Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months ] [ Designated as safety issue: Yes ]
    Immunogenicity assessments of PF-05082566

  • Anti-Drug Antibody (ADA) levels of KW-0761/Neutralizing antibodies (Nab) titers for KW-0761 [ Time Frame: Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months ] [ Designated as safety issue: Yes ]
    Immunogenicity assessments of KW-0761

  • Number of participants with Objective Response [ Time Frame: Every 8 weeks up to 24 months ] [ Designated as safety issue: No ]
    Number of participants with objective response (ie, confirmed complete or partial response according to RECIST version 1.1 and Immune Related Response Criteria (irRECIST))

  • Duration of Response (DR) [ Time Frame: Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months ] [ Designated as safety issue: No ]
    For participants in the expansion cohorts, who achieved on treatment a complete (CR) or partial (PR) response as per RECIST version 1.1 and irRECIST. DR is the time in days between the first date of documentation of CR or PR and the date of tumor progression or death due to any cause, whichever occurred first

  • Time to Response (TTR) [ Time Frame: Every 8 weeks up to 24 months ] [ Designated as safety issue: No ]
    For participant to the expansion cohort only. TTR is defined as time from the date of the first dose of study treatment to the date of the first documented objective response by RECIST version 1.1 and irRECIST

  • Progression Free Survival (PFS) [ Time Frame: Every 8 weeks up to 24 months ] [ Designated as safety issue: No ]
    For participants to the expansion cohorts only. PFS is defined as the difference in days between the first date that criteria for progression (by RECIST v 1.1 and irRECIST) was met or the patient died due to any cause and the date of registration


Estimated Enrollment: 70
Study Start Date: May 2015
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05082566 + KW-0761
During Parts 1 & 2 Mogamulizumab and PF-05082566 will be administered at appropriate intervals. Part 1: PF-05082566 dose escalation; increased doses of PF-05082566 IV are administered with mogamulizumab IV. Part 2: patients will be treated with the maximum tolerated dose established in Phase 1 for the combination.
Drug: PF-05082566
Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.
Drug: KW-0761
Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.
Other Name: KW-0761= Mogamulizumab or POTELIGEO®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available.
  • Measurable disease by RECIST version 1.1.
  • For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred).
  • Age 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate bone marrow, renal and liver function.
  • Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment.
  • Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment.

Exclusion Criteria:

  • Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
  • Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.
  • Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed.
  • Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration.
  • Live vaccine within 30 days prior to registration.
  • Severe hypersensitivity reaction to treatment with another monoclonal antibody, known or suspected hypersensitivity to study drugs or any component of their formulation.
  • History of autoimmune disease or known inflammatory bowel disease.
  • Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval >470 msec.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02444793

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92037-0845
UC San Diego Medical Center - La Jolla(Thornton Hospital) Recruiting
La Jolla, California, United States, 92037
University Of California / San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Principal Investigator: Esra E Cohen, MD         
UC San Diego Medical Center - Hillcrest Recruiting
San Diego, California, United States, 92103
United States, District of Columbia
Georgetown University Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20007
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Principal Investigator: Michael J Pishvaian, MD, PhD         
Medstar Georgetown University Hospital Active, not recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Moffitt Cancer Center and Research Institute Not yet recruiting
Tampa, Florida, United States, 33612
United States, Michigan
Henry Ford Hospital Research Pharmacy Recruiting
Detroit, Michigan, United States, 48202
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
United States, Nevada
Comprehensive Cancer Centers of Nevada Not yet recruiting
Las Vegas, Nevada, United States, 89169
United States, North Carolina
UNC Cancer Hospital Infusion Pharmacy Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals, University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
Cleveland Clinic Taussig Cancer Institute Active, not recruiting
Cleveland, Ohio, United States, 44195
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Dale R Shepard, MD, PhD         
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, South Dakota
Sanford Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 57104
Sanford Research Recruiting
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Tennessee Oncology, PLLC Not yet recruiting
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute Not yet recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Pfizer
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Michael J Pishvaian, MD, PhD Georgetown University
Principal Investigator: Esra E Cohen, MD University of California, San Diego
Principal Investigator: Dale R Shepard, MD, PhD The Cleveland Clinic
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02444793     History of Changes
Other Study ID Numbers: B1641004 
Study First Received: May 12, 2015
Last Updated: December 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016