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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

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: PF-06671008 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06671008 IN PATIENTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date : April 28, 2016
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : March 29, 2019

Arm Intervention/treatment
Experimental: PF-06671008 Drug: PF-06671008
Dose Escalation Phase - Part 1

Drug: PF-06671008
Dose Expansion Phase - Part 2




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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

  8. 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 ]
  9. 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 ]
  10. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659631


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center- Clinical Trials Office
New York, New York, United States, 10017
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York, New York, United States, 10022
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02659631     History of Changes
Other Study ID Numbers: B7831001
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Pfizer:
P-cadherin
PF-06671008
solid tumors
lung cancer
breast cancer
colorectal cancer
NSCLC
TNBC
CRC
neoplasms
Triple negative breast cancer
Non-small cell lung cancer