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A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors

Last updated on November 19, 2019

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Study Location
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Breast Cancer
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 advanced/metastatic solid tumor that is resistant to standard therapy or
for which no standard therapy is available

- Previously treated metastatic triple negative breast cancer that expresses Notch3
with at least one measurable lesion

- Adequate bone marrow, renal and liver function

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

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

- Patients with known symptomatic brain metastases requiring steroids

- Prior treatment with a compound of the same mechanism

NCT02129205
Pfizer
Active, not recruiting
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors

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Descriptive Information
Brief Title  ICMJE A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
Official Title  ICMJE A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06650808 IN PATIENTS WITH ADVANCED SOLID TUMORS
Brief SummaryTo assess the safety and tolerability at increasing dose levels of PF-06650808 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 Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Breast Cancer
Intervention  ICMJE
  • Drug: PF-06650808
    Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
  • Drug: PF-06650808
    Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Study Arms  ICMJE Experimental: PF-06650808
Interventions:
  • Drug: PF-06650808
  • Drug: PF-06650808
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: July 24, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2014)
55
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion DateJuly 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available
  • Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
  • Adequate bone marrow, renal and liver function

Exclusion Criteria:

  • Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of starting study treatment
  • Patients with known symptomatic brain metastases requiring steroids
  • Prior treatment with a compound of the same mechanism
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 NCT02129205
Other Study ID Numbers  ICMJE B7501001
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 Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

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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