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A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors

Last updated on November 13, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced 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.
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- Histological or cytological diagnosis of advanced solid tumors that is resistant to
standard therapy or for which no standard therapy is available.

- Age ≥18 years.

- ECOG Performance Status (PS) must be 0 or 1.

- Adequate Bone Marrow Function

- Adequate Renal Function

- Adequate Liver Function

- Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

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

- Patients with known brain metastases

- Major surgery within 4 weeks of starting study treatment

- Radiation therapy within 2 weeks of starting study treatment

- Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study
treatment

- Previous high dose chemotherapy requiring stem cell rescue

- Prior irradiation to >25% of the bone marrow

- Prior treatment with a Notch signal inhibitor

- Known malabsorption syndrome or other condition that may impair absorption of study
medication

- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism

- Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors

- Current use or anticipated need for known strong CYP3A4 inducers

NCT02462707
Pfizer
Withdrawn
A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors

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Descriptive Information
Brief Title  ICMJE A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors
Official Title  ICMJE Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors
Brief SummaryThe purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: PF-03084014
gamma-secretase inhibitor, formulated in tablets for oral administration containing 10 mg, 50 mg and 100 mg. Patient will receive 80 mg, 100 mg or 150 mg twice daily of PF-03084014 with continuous dosing schedule
Study Arms  ICMJE Experimental: PF-03084014
Intervention: Drug: PF-03084014
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 3, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2015)
12
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion DateJune 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
  • Age ?18 years.
  • ECOG Performance Status (PS) must be 0 or 1.
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function
  • Resolved acute effects of any prior therapy to baseline severity or Grade ?1

Exclusion Criteria:

  • Patients with known brain metastases
  • Major surgery within 4 weeks of starting study treatment
  • Radiation therapy within 2 weeks of starting study treatment
  • Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
  • Previous high dose chemotherapy requiring stem cell rescue
  • Prior irradiation to >25% of the bone marrow
  • Prior treatment with a Notch signal inhibitor
  • Known malabsorption syndrome or other condition that may impair absorption of study medication
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
  • Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
  • Current use or anticipated need for known strong CYP3A4 inducers
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02462707
Other Study ID Numbers  ICMJE A8641021
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2015

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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