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A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

Last updated on June 13, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
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

- Diagnosis of solid tumor that is advanced/metastatic and resistant to standard
therapy or for whom no standard therapy is available.

- Performance Status of 0 or 1. - Adequate bone marrow, kidney, and liver function.

- Part 2 includes ovarian cancer, target expressing triple negative breast cancer and
non small cell lung cancer patients.

- OVCA pts must have progressed while receiving or within 6mos after completion of at
least 4 cycles of platinum-containing regimen. Prior line of therapy up to 3
regimens.

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

- OVCA pts excluded with any of the following: non-epithelial, inlcuding malignant
mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only
disease, unresolved bowel obstruction, including sub-occlusive disease, related to
underlying disdease and history of abdominal fistula, GI perforation or
itra-abdominal abscess.

- Brain metastases requiring steroids

- Drug-drug interaction includes advanced metastatic breast cancer, ovarian cancer, or
non small cell lung cancer patients

- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
study treatment start

- Active and clinically significant bacterial, fungal, or viral infection

NCT02222922
Pfizer
Recruiting
A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

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A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647020 In Adult Patients With Advanced Solid Tumors
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
  • Drug: PF-06647020 Q3W

    Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.

    Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.

  • Drug: fluconazole
    combination drug used for drug-drug interaction sub-study
  • Drug: PF-06647020 Q2W

    Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined.

    Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.

  • Drug: PF-06647020 combined with Avelumab
    Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
  • Experimental: PF-06647020 Q3W
    Investigational drug infused over 60 minutes once every 21 days.
    Intervention: Drug: PF-06647020 Q3W
  • Experimental: Drug-drug interaction (DDI)
    PF-06647020 combined with fluconazole
    Intervention: Drug: fluconazole
  • Experimental: PF-06647020 Q2W
    Investigational drug infused over 60 minutes once every 14 days (28 day cycle)
    Intervention: Drug: PF-06647020 Q2W
  • Experimental: PF-06647020 combined with Avelumab
    PF-06647020 combined with Avelumab administered by infusion
    Intervention: Drug: PF-06647020 combined with Avelumab
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
July 24, 2019
July 24, 2019   (Final data collection date for primary outcome measure)

Q2W Inclusion Criteria:

  • Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
  • Performance Status of 0, 1, or 2
  • Adequate bone marrow, kidney, and liver function

Q2W Exclusion Criteria:

  • OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
  • Active and clinically significant bacterial, fungal, or viral infection

Q3W Inclusion Criteria:

  • Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
  • Performance Status of 0 or 1
  • Adequate bone marrow, kidney, and liver function
  • Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients

Q3W Exclusion Criteria:

  • OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction
  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
  • Active and clinically significant bacterial, fungal, or viral infection
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Spain,   United States
 
 
NCT02222922
B7661001
2014-003296-36 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

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