Clinical trial NCT01876251: A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
Official title: Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer Metastatic
Keywords: Breast cancer metastatic
docetaxel
PF-03084014
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-06-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1
timeFrame: Cycle 1 Days 1-21
measure: Progression-free Survival (PFS) at 6 Months - Expansion Cohort
timeFrame: Baseline till 6 months post-dose
Secondary outcomes:
measure: Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
timeFrame: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, every 6 weeks from Cycle 2 onwards up to 26 months
measure: Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort
timeFrame: Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)
measure: AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: Cmax of Docetaxel in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: Tmax of Docetaxel in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort
timeFrame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
measure: AUClast of PF-03084014 in the Expansion Cohort
timeFrame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
measure: Cmax of PF-03084014 in the Expansion Cohort
timeFrame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
measure: Tmax of PF-03084014 in the Expansion Cohort
timeFrame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
measure: Ctrough of PF-03084014 in the Expansion Cohort
timeFrame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
measure: Duration of Response (DR)
timeFrame: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
measure: Number of Participants With QTc Values Meeting Categorical Summarization Criteria
timeFrame: Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)
measure: Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood
timeFrame: C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, IDS Pharmacy
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Stanford
country: United States
facility: Stanford Hospital & Clinics-DRUG SHIPMENT ADDRESS only
state: California
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
city: Stanford
country: United States
facility: Stanford Women's Cancer Center
state: California
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute (KCI)
state: Michigan
city: Chapel Hill
country: United States
facility: UNC Cancer Hospital Infusion Pharmacy
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals, The University of North Carolina at Chapel Hill
state: North Carolina
city: Bruxelles
country: Belgium
facility: Jules Bordet Institut
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Milano
country: Italy
facility: Instituto Europeo di Oncologia
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia de L'Hospitalet de Llobregat(ICO)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: