Study Stopped
The study was terminated due to a change in sponsor prioritization.
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06650808 IN PATIENTS WITH ADVANCED SOLID TUMORS
1 other identifier
interventional
40
1 country
11
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06650808 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 P50-P75 for phase_1
Started Jun 2014
Typical duration for phase_1
11 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 30, 2014
CompletedFirst Posted
Study publicly available on registry
May 2, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
March 29, 2019
CompletedMarch 29, 2019
December 1, 2018
3.1 years
April 30, 2014
June 12, 2018
December 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)
Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade\>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia \>=72 hours or platelets\<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade\>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.
Day 1 up to Day 21
Percentage of Participants With Objective Response (Part 1 and Part 2)
Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR.
Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years
Secondary Outcomes (13)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)
3 years
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
3 years
- +8 more secondary outcomes
Study Arms (1)
PF-06650808
EXPERIMENTALInterventions
Dose Escalation Phase \[Part 1\] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
Eligibility Criteria
You may qualify if:
- Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available
- Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
- Adequate bone marrow, renal and liver function
You may not qualify if:
- Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of starting study treatment
- Patients with known symptomatic brain metastases requiring steroids
- Prior treatment with a compound of the same mechanism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (11)
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
Westwood Bowyer Clinic
Los Angeles, California, 90095, United States
Santa Monica - UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210, United States
The OSU Investigational Drug Services
Columbus, Ohio, 43210, United States
The OSU Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212, United States
The Ohio State University Martha Morehouse Medical Plaza
Columbus, Ohio, 43221, United States
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229, United States
Related Publications (1)
Rosen LS, Wesolowski R, Baffa R, Liao KH, Hua SY, Gibson BL, Pirie-Shepherd S, Tolcher AW. A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest New Drugs. 2020 Feb;38(1):120-130. doi: 10.1007/s10637-019-00754-y. Epub 2019 Mar 18.
PMID: 30887250DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated as a business decision prior to the start of the dose expansion stage.
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 30, 2014
First Posted
May 2, 2014
Study Start
June 1, 2014
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
March 29, 2019
Results First Posted
March 29, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share
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.