Asian Phase I Study Of PF-03446962

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01337050
First received: April 6, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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].


Condition Intervention Phase
Neoplasms
Drug: PF-03446962
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I Pharmacokinetic And Pharmacodynamic Study Of PF-03446962 In Asian Patient With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Recommended Phase 2 Dose [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Peak plasma concentration (Cmax) of PF-03446962 [ Time Frame: 0, 0.5, 1, 1.6, 2, 5, 8, 24, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, every cycle ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of PF-03446962 [ Time Frame: 0, 0.5, 1, 1.6, 2, 5, 8, 24, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, every cycle ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Maximum drug concentration time(Tmax) of PF-03446962 [ Time Frame: 0, 0.5, 1, 1.6, 2, 5, 8, 24, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, every cycle ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Lowest drug concentration (Cmin) of PF-03446962 [ Time Frame: 0, 0.5, 1, 1.6, 2, 5, 8, 24, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, every cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the effect of Human anti-human antibody (HAHA) concentration of PF-03446962 for each dosing level [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Best Overall Response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
PF-03446962
Drug: PF-03446962
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337050

Locations
Japan
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01337050     History of Changes
Other Study ID Numbers: A8471004
Study First Received: April 6, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hepatocellular Carcinoma
Advanced/Metastatic solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014