Clinical trial NCT01337050: Asian Phase I Study Of PF-03446962
Official title: A Phase I Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Asian Patient With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Hepatocellular Carcinoma
Advanced/Metastatic solid tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose \[MTD\] and the Recommended Phase 2 Dose \[RP2D\].


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of stomach cancer
* advanced/metastasis solid tumor refractory or intolerant to established therapy
* adequate blood chemistry, blood counts and kidney/liver function
* willing to participate to study requirements and sign an informed consent document

Exclusion Criteria:

* Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
* excessive toxicities related to prior therapies
* pregnant or breastfeeding patients

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Baseline up to Week 6
measure: Recommended Phase-2 Dose (RP2D)
timeFrame: Baseline up to 28 days after last dose of study medication
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to 28 days after last dose
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Minimum Observed Serum Trough Concentration (Cmin)
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Area Under the Curve From Time Zero to 28 Days [AUC (0-28)]
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Systemic Clearance (CL)
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Volume of Distribution (Vd)
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1
measure: Soluble Proteins Level
timeFrame: Baseline, Day 1, 0 hour (H), 6 H Cycle 1 Day 1, Day 22 of Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3 and end of treatment (up to cycle 30)
measure: Number of Participants With Human Anti-Human Antibody (HAHA)
timeFrame: Baseline, Post-dose (Day 1 of every Cycle up to 28 days after last dose) up to Cycle 30
measure: Number of Participants With Best Overall Response (BOR)
timeFrame: Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)
measure: Number of Participants With Clinical Benefit Response (CBR)
timeFrame: Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)
measure: Progression Free Survival (PFS)
timeFrame: Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital/Department of Internal Medicine
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: