You are here

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

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
UC San Diego Moores Cancer Center
La Jolla, California, 92037-0845 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced/Metastatic Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02444793
Pfizer
Terminated
A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
Official Title  ICMJE A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced/Metastatic Solid Tumors
Intervention  ICMJE
  • 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®
Study Arms  ICMJE 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.
Interventions:
  • Drug: PF-05082566
  • Drug: KW-0761
Publications *Not Provided


*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 8, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2015)
70
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion DateSeptember 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT02444793
Other Study ID Numbers  ICMJE B1641004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Kyowa Kirin Co., Ltd.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Principal Investigator:Michael J Pishvaian, MD, PhDGeorgetown University
Principal Investigator:Esra E Cohen, MDUniversity of California, San Diego
Principal Investigator:Dale R Shepard, MD, PhDThe Cleveland Clinic
PRS AccountPfizer
Verification DateFebruary 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now