Study Stopped
The study was prematurely discontinued due to a business-related decision on 09-FEB-2016. The decision to terminate the trial was based on the overall results.
A Study Of PF-06664178 In Patients With Advanced Solid Tumors
A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors
2 other identifiers
interventional
31
1 country
10
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2014
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
February 19, 2018
CompletedFebruary 19, 2018
August 1, 2017
1.8 years
April 17, 2014
April 25, 2017
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Day 1 up to Day 21
Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
Day 1 up to Day 21
Number of Participants With Laboratory Abnormalities [Part 2 & 3]
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.
On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)
Secondary Outcomes (25)
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1]
From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)
Number of Participants With Laboratory Abnormalities[Part 1]
Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)
Overall Incidence of Anti-PF-06664178-Antibodies[Part 1]
Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3]
Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
Overall Number of Participants With Objective Tumor Response[Part 1]
Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
- +20 more secondary outcomes
Study Arms (1)
PF-06664178
EXPERIMENTALExperimental
Interventions
Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.
Eligibility Criteria
You may qualify if:
- 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 NSCLC, ovarian or breast cancer patients
You may not qualify if:
- Brain metastases requiring steroids
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
- Active and clinically significant bacterial, fungal, or viral infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
Keck Hospital of USC
Los Angeles, California, 90033, United States
LAC&USC Medical Center
Los Angeles, California, 90033, United States
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
University of Colorado Denver CTO (CTRC)
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated prematurely for business reasons
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2014
First Posted
April 24, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
February 19, 2018
Results First Posted
February 19, 2018
Record last verified: 2017-08