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

Last updated on May 10, 2018

FOR MORE INFORMATION
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.
Show details

- 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Withdrawn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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A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors
Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors
The 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.
Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
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
Experimental: PF-03084014
Intervention: Drug: PF-03084014
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02462707
A8641021
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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