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

This study has been terminated.
(The study was terminated on June 23, 2015 due to the company's change in prioritization for the portfolio and is not due to any safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01891669
First received: June 10, 2013
Last updated: May 17, 2016
Last verified: May 2016
  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 ]
    DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.


Secondary Outcome Measures:
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade [ Time Frame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up. ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.

  • Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade [ Time Frame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up. ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.

  • Number of Participants With Hematological Test Abnormalities in All Cycles. [ Time Frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment ] [ Designated as safety issue: Yes ]
    Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.

  • Number of Participants With Chemistry Test Abnormalities in All Cycles. [ Time Frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment ] [ Designated as safety issue: Yes ]
    Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.

  • Number of Participants With Abnormalities in Urine Protein in All Cycles. [ Time Frame: Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment ] [ Designated as safety issue: Yes ]
    Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.

  • Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria [ Time Frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up. ] [ Designated as safety issue: Yes ]
    Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).

  • Number of Participants With Positive Anti-PF-06263507 Antibody [ 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 ]
    The number of participants with positive anti-PF-06263507 antibody.

  • Number of Participants With Best Overall Response (BOR) [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months. ] [ Designated as safety issue: Yes ]
    Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

  • Objective Response [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months. ] [ Designated as safety issue: Yes ]
    Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.

  • Overall Survival [ Time Frame: Baseline to death ] [ Designated as safety issue: Yes ]
    Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.

  • Time to Reach Maximum Observed Serum PF-06263507 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 ]
  • Time to Reach Maximum Observed Serum PF-06281192 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 ]
  • Time to Reach Maximum Observed Serum PF-06264490 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 ]

Enrollment: 26
Study Start Date: August 2013
Study Completion Date: June 2015
Primary Completion Date: June 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   (Adult, Senior)
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

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Drug Shipped To: Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01891669     History of Changes
Other Study ID Numbers: B4481001 
Study First Received: June 10, 2013
Results First Received: May 17, 2016
Last Updated: May 17, 2016
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:
Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on December 09, 2016