Asian Phase I Study Of PF-03446962

NCT01337050 | Completed Phase 1 Results

• 1 other identifier: A8471004
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

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 \[RP2D\].

Conditions

Neoplasms

Keywords

Hepatocellular Carcinoma; Advanced/Metastatic solid tumors

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than \[\< \])500/cubic millimeter \[mm\^ 3\]) lasting for greater than equal to (\>=) 8 days; Febrile Neutropenia \>= Grade 3; Neutropenic Infection \>= Grade 3; Grade 4 thrombocytopenia (\<25,000/mm\^3); Grade 3 thrombocytopenia (\<50,000/mm\^3) with active bleeding; Grade 3 or higher non-hematological toxicity.

  Baseline up to Week 6

• Recommended Phase-2 Dose (RP2D)

  RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.

  Baseline up to 28 days after last dose of study medication

Secondary Outcomes (17)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 28 days after last dose

• Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity

  Baseline up to 28 days after last dose

• Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 28 days after last dose

• Number of Participants With Laboratory Abnormalities

  Baseline up to 28 days after last dose

• Maximum Observed Serum Concentration (Cmax)

  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

Study Arms (1)

A

EXPERIMENTAL

PF-03446962

Drug: PF-03446962

Interventions

PF-03446962 DRUG

PF 03446962 given by a 1 hour IV infusion. Each patient will initially receive the first dose on Cycle 1 Day 1 with a 28 day observation period. Cycle 2 will start on Day 29. The dosing interval will be 14 days for Cycle 2 and subsequent cycles.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Seoul National University Hospital/Department of Internal Medicine

Seoul, 110-744, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neoplasms; Carcinoma, Hepatocellular

Interventions

ascrinvacumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 18, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 28, 2015
• Results First Posted: August 28, 2015

Record last verified: 2015-10

Locations

JP (1); KR (1)