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

Last updated on March 22, 2018

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

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A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
A Phase 1b Study Of Pf-05082566 In Combination With Mogamulizumab (Kw-0761) In Patients With Advanced Solid Tumors
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.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced/Metastatic Solid Tumors
  • 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®
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
October 2017
September 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02444793
B1641004
No
Not Provided
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Kyowa Hakko Kirin Co., Ltd
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
Pfizer
October 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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