A Study Of PF-06263507 In Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01891669
First received: June 10, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.


Condition Intervention Phase
Neoplasms
Carcinoma, Non Small Cell Lung
Breast Neoplasms
Ovarian Neoplasms
Drug: PF-06263507
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Dose Escalation Study Of PF-06263507 In Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: Baseline up to Cycle 2 Day 1 (22 days) ] [ Designated as safety issue: Yes ]
    First cycle DLTs in order to determine maximum tolerated dose


Secondary Outcome Measures:
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose ] [ Designated as safety issue: No ]
    Tmax will be calculated for total antibody, and unconjugated payload

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Baseline,Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose, Day 5, Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose, 1,8,12,24 hr post dose, Day 8 and Day 15, every cycle thereafter on Day 1 pre-dose, and up to 21 days after the last dose ] [ Designated as safety issue: No ]
    Cmax will be calculated for total antibody, and unconjugated payload

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Baseline, Cycle1 Day1 pre-dose,1,4,8,2,24,and 48hrs post dose, Day5, Day8 and Day15;Day 1 of Cycle2 and 3,Day 1 of Cycle4 pre-dose,1,8,12,24hr post dose, Day 8 and Day 15, every cycle thereafter on Day 1 pre-dose, and up to 21 days after the last dose ] [ Designated as safety issue: No ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  • Volume of Distribution at Steady State (Vss) [ Time Frame: Baseline,Cycle1 Day1 pre-dose,1,4,8,12,24,and 48hrs post dose, Day5,Day8 and Day15;Day1 of Cycle2 and 3, Day1 of Cycle4 pre-dose,1,8,12,24hr post dose, Day8 and Day15, every cycle thereafter on Day 1 pre-dose, and up to 21 days after the last dose ] [ Designated as safety issue: No ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

  • Plasma Decay Half-Life (t1/2) [ Time Frame: Baseline,Cycle1 Day1 pre-dose,1,4,8,12,24, and 48hrs post dose, Day5, Day8 and Day15; Day1 of Cycle2 and 3, Day1 of Cycle4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on Day 1 pre-dose, and up to 21 days after the last dose ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Incidence of anti-drug antibodies [ Time Frame: Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Number of Participants With Objective Response [ Time Frame: Baseline, Every 6 weeks until disease progression or unacceptable toxicity up to 24 months ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

  • Progression-Free Survival (PFS) [ Time Frame: Baseline, Every 6 weeks until disease progression or unacceptable toxicity up to 24 months ] [ Designated as safety issue: No ]
    Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7


Estimated Enrollment: 105
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Drug: PF-06263507
Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.
Drug: PF-06263507
Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.
  • Performance Status of 0 or 1.
  • Adequate bone marrow, kidney, liver, and heart function.

Exclusion Criteria:

  • Brain metastases requiring steroids.
  • Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
  • Active bacterial, fungal or viral infection.
  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: NCT01891669

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, Georgia
Pfizer Investigational Site Recruiting
Marietta, Georgia, United States, 30067
United States, Massachusetts
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02215USA
United States, Michigan
Pfizer Investigational Site Recruiting
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Pfizer Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
Pfizer Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19111 USA
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: NCT01891669     History of Changes
Other Study ID Numbers: B4481001
Study First Received: June 10, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
ADC 5T4
PF-06263507
solid tumors
lung cancer
breast cancer
ovarian cancer
cancer
tumors
neoplasm metastasis

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Ovarian Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014