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



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:May 2015
End Date:October 2017

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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.


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.
We found this trial at
22
sites
3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Dale R Shepard, MD, PhD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Chapel Hill, North Carolina 27514
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Detroit, Michigan 48202
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Gallatin, Tennessee 37066
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La Jolla, California 92093
Principal Investigator: Esra E Cohen, MD
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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San Diego, California 92103
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Sioux Falls, South Dakota 57104
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Sioux Falls, South Dakota 65104
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Sioux Falls, South Dakota 57117
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington, District of Columbia 20007
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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