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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014