NCT02462707
Withdrawn
Phase 1
Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Pfizer
- Primary Endpoint
- First-cycle Dose Limiting Toxicities
Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
PF-03084014
Experimental
Intervention: PF-03084014 (Drug)
Outcomes
Primary Outcomes
First-cycle Dose Limiting Toxicities
Time Frame: during the first 28 days from the first dose
Secondary Outcomes
- Maximum Observed Plasma Concentration (Cmax)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Apparent Oral Clearance (CL/F)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Apparent Volume of Distribution at steady state (Vss/F)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Minimum Observed Plasma Trough Concentration (Cmin)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Average Serum Concentration at steady state (Cav)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- QTc interval(from the first dose to the last dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(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)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Plasma Decay Half-Life (t1/2)(0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose)
- Accumulation Ratio (Rac)(0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21)
Investigators
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