A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02222922
First received: August 20, 2014
Last updated: October 11, 2014
Last verified: October 2014
  Purpose

To assess the safety and tolerability at increasing dose levels of PF-06647020 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
Drug: PF-06647020
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 First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647020 In Adult 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) {Part1} [ Time Frame: Day 1 up to Day 21 ] [ Designated as safety issue: Yes ]
    First cycle DLTs in order to determine maximum tolerated dose


Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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.

  • Volume of distribution (Vd) [ 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 (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.

  • Accumulation ratio (Rac) [ 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 Last Quantifiable Concentration [AUC (0-t)] [ 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 ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  • Incidence of anti-drug antibodies [ Time Frame: Days 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-06647020 antibodies

  • Number of participants with objective response (Part 1) [ 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 response rate (RR)

  • Number of participants with objective response (Part 2) [ 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 overall response rate (ORR) and progression free survival (PFS)


Estimated Enrollment: 82
Study Start Date: November 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06647020 Drug: PF-06647020
Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.
Drug: PF-06647020
Part 2: Patients with select tumor types (triple negative breast cancer and non small cell lung cancer) 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 whom no standard therapy is available
  • Performance Status of 0 or 1
  • Adequate bone marrow, kidney, and liver function
  • Part 2 includes target expressing triple negative breast cancer or non small cell lung cancer patients

Exclusion Criteria:

  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
  • Active and clinically significant 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: NCT02222922

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

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: NCT02222922     History of Changes
Other Study ID Numbers: B7661001
Study First Received: August 20, 2014
Last Updated: October 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
ADC
PF-06647020
solid tumors
tumors
neoplasm metastasis
TNBC
triple negative breast cancer
NSCLC
non small cell lung cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014