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Trial record 1 of 1 for:    NCT02659631
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PF-06671008 Dose Escalation Study in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02659631
Recruitment Status : Terminated
First Posted : January 20, 2016
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 15, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE April 28, 2016
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Number of participants with Dose-Limiting Toxicities (DLT) [Part 1] [ Time Frame: Baseline through Day 21 ]
    First cycle DLTs in order to determine the maximum tolerated dose
  • Number of participants with objective response [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Objective response as determined by RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02659631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72, 96 hrs post, D8 0, 2, 4, 8, 24, 48, 72 hrs post, D15 0, 2 hrs post, C2D1 0, 2, 4, 8, 24, 48, 72 hrs post, D8 and D15 0, 2 hrs post, 0, 2 hrs post additional dosings, up to 24 months ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72, 96 hrs post, D8 0, 2, 4, 8, 24, 48, 72 hrs post, D15 0, 2 hrs post, C2D1 0, 2, 4, 8, 24, 48, 72 hrs post, D8 and D15 0, 2 hrs post, 0, 2 hrs post additional dosings, up to 24 months ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72, 96 hrs post, D8 0, 2, 4, 8, 24, 48, 72 hrs post, D15 0, 2 hrs post, C2D1 0, 2, 4, 8, 24, 48, 72 hrs post, D8 and D15 0, 2 hrs post, 0, 2 hrs post additional dosings, up to 24 months ]
  • Area Under the Curve from Time Zero to End of Dosing Interval (AUCtacu) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72, 96 hrs post, D8 0, 2, 4, 8, 24, 48, 72 hrs post, D15 0, 2 hrs post, C2D1 0, 2, 4, 8, 24, 48, 72 hrs post, D8 and D15 0, 2 hrs post, 0, 2 hrs post additional dosings, up to 24 months ]
  • Area Under the Curve from time zero to infinity (AUCinf) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72, 96 hrs post, D8 0, 2, 4, 8, 24, 48, 72 hrs post, D15 0, 2 hrs post, C2D1 0, 2, 4, 8, 24, 48, 72 hrs post, D8 and D15 0, 2 hrs post, 0, 2 hrs post additional dosings, up to 24 months ]
  • Systemic Clearance or Apparent Clearance [ Time Frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72, 96 hrs post, D8 0, 2, 4, 8, 24, 48, 72 hrs post, D15 0, 2 hrs post, C2D1 0, 2, 4, 8, 24, 48, 72 hrs post, D8 and D15 0, 2 hrs post, 0, 2 hrs post additional dosings, up to 24 months ]
  • Number of participants with objective response (Part 1) [ Time Frame: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression, unacceptable toxicity, or up to 24 months ]
    Response rate by RECIST v1.1
  • Number of participants with PFS (Part 2) [ Time Frame: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 months ]
  • Number of participants with OS (Part 2) [ Time Frame: Baseline and every 6 weeks until disease progression or unacceptable toxicity, or up to 24 months ]
  • Incidence and titers of anti drug antibodies (ADA) and neutralizing antibodies against PF 06671008 [ Time Frame: C1D1 0 hrs, D15 0 hrs, and C2D1 0 hrs, and D1 0 hrs post additional dosings, up to 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24 hrs post, D4, D8 0, 1, 2, 4, 8, 24 hrs post, D11, D15 0, 1 or 2 hrs post, C2D1 0, 1 or 2, 4, 24 hrs post, D4, D8 and D15 0, 1 or 2 hrs post, 0, 1 or 2 hrs post on D1, 8 and 15 of subsequent cycles, and up to 24 months ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24 hrs post, D4, D8 0, 1, 2, 4, 8, 24 hrs post, D11, D15 0, 1 or 2 hrs post, C2D1 0, 1 or 2, 4, 24 hrs post, D4, D8 and D15 0, 1 or 2 hrs post, 0, 1 or 2 hrs post on D1, 8 and 15 of subsequent cycles, and up to 24 months ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24 hrs post, D4, D8 0, 1, 2, 4, 8, 24 hrs post, D11, D15 0, 1 or 2 hrs post, C2D1 0, 1 or 2, 4, 24 hrs post, D4, D8 and D15 0, 1 or 2 hrs post, 0, 1 or 2 hrs post on D1, 8 and 15 of subsequent cycles, and up to 24 months ]
  • Area Under the Curve from Time Zero to End of Dosing Interval (AUCtacu) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24 hrs post, D4, D8 0, 1, 2, 4, 8, 24 hrs post, D11, D15 0, 1 or 2 hrs post, C2D1 0, 1 or 2, 4, 24 hrs post, D4, D8 and D15 0, 1 or 2 hrs post, 0, 1 or 2 hrs post on D1, 8 and 15 of subsequent cycles, and up to 24 months ]
  • Area Under the Curve from time zero to infinity (AUCinf) [ Time Frame: C1D1 0, 1, 2, 4, 8, 24 hrs post, D4, D8 0, 1, 2, 4, 8, 24 hrs post, D11, D15 0, 1 or 2 hrs post, C2D1 0, 1 or 2, 4, 24 hrs post, D4, D8 and D15 0, 1 or 2 hrs post, 0, 1 or 2 hrs post on D1, 8 and 15 of subsequent cycles, and up to 24 months ]
  • Systemic Clearance [ Time Frame: C1D1 0, 1, 2, 4, 8, 24 hrs post, D4, D8 0, 1, 2, 4, 8, 24 hrs post, D11, D15 0, 1 or 2 hrs post, C2D1 0, 1 or 2, 4, 24 hrs post, D4, D8 and D15 0, 1 or 2 hrs post, 0, 1 or 2 hrs post on D1, 8 and 15 of subsequent cycles, and up to 24 months ]
  • Number of participants with objective response (Part 1) [ Time Frame: Baseline and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months ]
    Response rate by RECIST v1.1
  • Number of participants with PFS (Part 2) [ Time Frame: Baseline and every 6 weeks until disease progression or unacceptable toxicity, or up to 24 months ]
  • Number of participants with OS (Part 2) [ Time Frame: Baseline and every 6 weeks until disease progression or unacceptable toxicity, or up to 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PF-06671008 Dose Escalation Study in Advanced Solid Tumors
Official Title  ICMJE A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06671008 IN PATIENTS WITH ADVANCED SOLID TUMORS
Brief Summary The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin expression. The study will then expand to look at the selected dose in patients with P-cadherin expressing TNBC, CRC or NSCLC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: PF-06671008
    Dose Escalation Phase - Part 1
  • Drug: PF-06671008
    Dose Expansion Phase - Part 2
Study Arms  ICMJE Experimental: PF-06671008
Interventions:
  • Drug: PF-06671008
  • Drug: PF-06671008
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 9, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
110
Actual Study Completion Date  ICMJE March 29, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

  • Diagnosis of tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available
  • Performance status of 0 or 1
  • Adequate bone marrow, kidney and liver function

Key Exclusion Criteria

  • Known CNS disease including, but not limited to, metastases
  • Current or history of seizure disorder
  • History of or active autoimmune disorders
  • Active bacterial, fungal or viral infection
  • Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study treatment
  • Requirement for systemic immune suppressive medication
  • Grade 2 or greater peripheral neuropathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02659631
Other Study ID Numbers  ICMJE B7831001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP