A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer

NCT01876251 | Terminated Phase 1 Results

• 2 other identifiers: A86410162013-000659-41
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 16

Brief Summary

This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected.

Conditions

Breast Cancer Metastatic

Keywords

Breast cancer metastatic; docetaxel; PF-03084014

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1

  Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia (Grade more than or equal to \[\>=\] 3 and body temperature \>=38.5 degrees Celsius); Grade \>=3 neutropenic infection; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade \>=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.

  Cycle 1 Days 1-21

• Progression-free Survival (PFS) at 6 Months - Expansion Cohort

  The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Baseline till 6 months post-dose

Secondary Outcomes (19)

• Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs

  Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

• Number of Participants With Laboratory Abnormalities

  Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

• Percentage of Participants With Objective Response (OR)

  Baseline, every 6 weeks from Cycle 2 onwards up to 26 months

• Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort

  Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)

• AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort

  C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Study Arms (1)

PF-03084014 plus docetaxel

EXPERIMENTAL

PF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m\^2

Drug: PF-03084014; Drug: Docetaxel

Interventions

PF-03084014 DRUG

Tablet, 10 mg, twice a day

PF-03084014 plus docetaxel

Docetaxel DRUG

Solution for IV infusion 75 mg/m\^2, every 3 weeks

Also known as: Taxotere

PF-03084014 plus docetaxel

Eligibility Criteria

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

You may qualify if:

• Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.

You may not qualify if:

• Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, 35249, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Stanford Cancer Institute

Stanford, California, 94305, United States

Location

Stanford Hospital & Clinics-DRUG SHIPMENT ADDRESS only

Stanford, California, 94305, United States

Location

Stanford Hospital & Clinics

Stanford, California, 94305, United States

Location

Stanford Women's Cancer Center

Stanford, California, 94305, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute (KCI)

Detroit, Michigan, 48201, United States

Location

UNC Cancer Hospital Infusion Pharmacy

Chapel Hill, North Carolina, 27514, United States

Location

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7600, United States

Location

Jules Bordet Institut

Brussels, 1000, Belgium

Location

Grand Hopital de Charleroi

Charleroi, 6000, Belgium

Location

Instituto Europeo di Oncologia

Milan, 20141, Italy

Location

Instituto Catalan de Oncologia de L'Hospitalet de Llobregat(ICO)

Barcelona, 08908, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Links

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

MeSH Terms

Interventions

nirogacestat; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

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: June 12, 2013
• Study Start: November 4, 2013
• Primary Completion: December 24, 2015
• Study Completion: December 24, 2015
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2019-03

Locations

ES (2); IT (1); BE (2); US (11)