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

NCT01891669 | Terminated Phase 1 Results

• 1 other identifier: B4481001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Neoplasms; Carcinoma, Non Small Cell Lung; Breast Neoplasms; Ovarian Neoplasms

Keywords

ADC 5T4; PF-06263507; solid tumors; lung cancer; breast cancer; ovarian cancer; cancer; tumors; neoplasm metastasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose-limiting Toxicities (DLT)

  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.

  Baseline up to Cycle 2 Day 1 (22 days)

Secondary Outcomes (13)

• 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

  Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.

• Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade

  Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.

• Number of Participants With Hematological Test Abnormalities in All Cycles.

  Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment

• Number of Participants With Chemistry Test Abnormalities in All Cycles.

  Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment

• Number of Participants With Abnormalities in Urine Protein in All Cycles.

  Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment

Study Arms (1)

Part 1

EXPERIMENTAL

Drug: PF-06263507

Interventions

PF-06263507 DRUG

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.

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 which no standard therapy is available.
• Performance Status of 0 or 1.
• Adequate bone marrow, kidney, liver, and heart function.

You may not qualify if:

• Brain metastases requiring steroids.
• Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
• Active bacterial, fungal or viral infection.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• Shapiro GI, Vaishampayan UN, LoRusso P, Barton J, Hua S, Reich SD, Shazer R, Taylor CT, Xuan D, Borghaei H. First-in-human trial of an anti-5T4 antibody-monomethylauristatin conjugate, PF-06263507, in patients with advanced solid tumors. Invest New Drugs. 2017 Jun;35(3):315-323. doi: 10.1007/s10637-016-0419-7. Epub 2017 Jan 9.

  PMID: 28070718 DERIVED

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Ovarian Neoplasms; Lung Neoplasms; Neoplasm Metastasis

Interventions

PF-06263507

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated prematurely before treatment in Part 2 started due to a business-related decision.

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

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
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: July 3, 2013
• Study Start: August 8, 2013
• Primary Completion: June 29, 2015
• Study Completion: June 29, 2015
• Last Updated: January 9, 2019
• Results First Posted: June 24, 2016

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)