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

Last updated on November 20, 2019

FOR MORE INFORMATION
Study Location
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , 28040 Spain
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
Completed
A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

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Descriptive Information
Brief Title  ICMJE A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
Official Title  ICMJE A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2019)
138
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2014)
82
Actual Study Completion Date  ICMJE November 5, 2019
Actual Primary Completion DateNovember 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02222922
Other Study ID Numbers  ICMJE B7661001
2014-003296-36 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
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 Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 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]

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