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Trial record 1 of 1 for:    NCT02462707
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A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02462707
Recruitment Status : Withdrawn
First Posted : June 4, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 2, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date October 7, 2015
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
First-cycle Dose Limiting Toxicities [ Time Frame: during the first 28 days from the first dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • QTc interval [ Time Frame: from the first dose to the last dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • Apparent Volume of Distribution at steady state (Vss/F) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • Average Serum Concentration at steady state (Cav) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose ]
  • Accumulation Ratio (Rac) [ Time Frame: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary 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.
Detailed Description Not 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 Date June 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP