Clinical trial NCT02462707: A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors
Official title: Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: First-cycle Dose Limiting Toxicities
timeFrame: during the first 28 days from the first dose
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: QTc interval
timeFrame: from the first dose to the last dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: Apparent Volume of Distribution at steady state (Vss/F)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: Average Serum Concentration at steady state (Cav)
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
measure: Accumulation Ratio (Rac)
timeFrame: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: