A Study Of PF-06647263 In Patients With Advanced Solid Tumors

NCT02078752 | Terminated Phase 1 Results

• 1 other identifier: B7521001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Conditions

Neoplasms; Triple-Negative Breast Cancer

Keywords

ADC; PF-06647263; solid tumors; tumors; neoplasm metastasis; TNBC; Triple negative breast cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1)

  DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting \>7 days; febrile neutropenia (defined as neutropenia \>=Grade 3 and a single body temperature \>38.3°C or a sustained temperature of \>=38°C for more than 1 hour); 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/mm\^3 regardless of duration. (2)Non- hematologic: bilirubin increase \>=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade \>=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.

  Baseline up to Cycle 2 Day 1 (22 days)

• Percentage of Participants With Objective Response (Part 2)

  Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved 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.

  Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Secondary Outcomes (28)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles)

  Baseline up to 28 days after the last treatment administration (Approximately 13 months)

• Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles)

  Baseline up to 28 days after the last treatment administration (Approximately 13 months)

• Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles)

  Baseline up to 28 days after the last treatment administration (Approximately 13 months)

• Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles)

  Baseline up to 28 days after the last treatment administration (Approximately 13 months)

• Number of Participants With Vital Signs Abnormalities

  Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)

Study Arms (1)

Part 1

EXPERIMENTAL

Drug: PF-06647263

Interventions

PF-06647263 DRUG

Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.

Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 advanced triple negative 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
• Active and clinically significant bacterial, fungal or viral infection

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital (BWH)

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Comprehensive Cancer Centers Of Nevada

Las Vegas, Nevada, 89169, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Hospital / University of Utah

Salt Lake City, Utah, 84112, United States

Location

Huntsman Cancer Institute-University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Garrido-Laguna I, Krop I, Burris HA 3rd, Hamilton E, Braiteh F, Weise AM, Abu-Khalaf M, Werner TL, Pirie-Shepherd S, Zopf CJ, Lakshminarayanan M, Holland JS, Baffa R, Hong DS. First-in-human, phase I study of PF-06647263, an anti-EFNA4 calicheamicin antibody-drug conjugate, in patients with advanced solid tumors. Int J Cancer. 2019 Oct 1;145(7):1798-1808. doi: 10.1002/ijc.32154. Epub 2019 Feb 23.

  PMID: 30680712 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neoplasms; Triple Negative Breast Neoplasms; Neoplasm Metastasis

Interventions

PF-06647263

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated due to sponsor's decision (for reasons other than safety) due to which data for few outcome measures was not analyzed and reported.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 5, 2014
• Study Start: April 9, 2014
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2017
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)