A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02129205
First received: April 30, 2014
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

To assess the safety and tolerability at increasing dose levels of PF-06650808 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
Breast Cancer
Drug: PF-06650808
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 Evaluating The Safety And Tolerability Of PF-06650808 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) [Part 1] [ Time Frame: Day 1 up to Day 21 ] [ Designated as safety issue: Yes ]
    First cycle DLTs in order to determine maximum tolerated dose

  • Number of participants with objective response [Part 2] [ Time Frame: Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months ] [ Designated as safety issue: No ]
    Response rate as determined by RECIST v 1.1


Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ] [ Designated as safety issue: No ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ] [ Designated as safety issue: No ]
  • Systemic Clearance (CL) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ] [ Designated as safety issue: No ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  • Incidence of anti-drug antibodies [ Time Frame: Day 1, 15, 21, and every 21 days thereafter up to 24 months ] [ Designated as safety issue: No ]
    Number of participants with the presence of anti-PF-06650808 antibodies

  • Number of participants with objective response, PFS and OS [Part 2] [ Time Frame: Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months ] [ Designated as safety issue: No ]
  • Volume of Distribution at Steady State (Vss) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ] [ 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: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.


Estimated Enrollment: 55
Study Start Date: July 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06650808 Drug: PF-06650808
Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
Drug: PF-06650808
Dose Expansion Phase [Part 2] - Patients 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 advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available
  • Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
  • Adequate bone marrow, renal and liver function

Exclusion Criteria:

  • Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of starting study treatment
  • Patients with known symptomatic brain metastases requiring steroids
  • Prior treatment with a compound of the same mechanism
  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: NCT02129205

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

Locations
United States, California
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90095
Pfizer Investigational Site Recruiting
Santa Monica, California, United States, 90404
United States, Ohio
Pfizer Investigational Site Not yet recruiting
Columbus, Ohio, United States, 43210
Pfizer Investigational Site Not yet recruiting
Columbus, Ohio, United States, 43221
Pfizer Investigational Site Not yet recruiting
Columbus, Ohio, United States, 43212
United States, Texas
Pfizer Investigational Site Recruiting
San Antonio, Texas, United States, 78229
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: NCT02129205     History of Changes
Other Study ID Numbers: B7501001
Study First Received: April 30, 2014
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
solid tumors
triple negative breast cancer
PF-06650808
Phase 1

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014