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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03284723




Registration number
NCT03284723
Ethics application status
Date submitted
1/09/2017
Date registered
15/09/2017
Date last updated
3/09/2024

Titles & IDs
Public title
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
Scientific title
A Phase 1 Dose Escalation Study Evaluating the Safety and Tolerability of PF-06804103 in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive and Negative Solid Tumors
Secondary ID [1] 0 0
2017-002538-22
Secondary ID [2] 0 0
C0541001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06804103
Treatment: Drugs - PF-06804103 + Palbociclib +Letrozole

Experimental: PF-06804103 - Study Treatment

Experimental: PF-06804103+Combination Regimen - Study Treatment


Treatment: Drugs: PF-06804103
Dose Escalation Part - 1A Dose Expansion Part - 2A

Treatment: Drugs: PF-06804103 + Palbociclib +Letrozole
Dose Escalation - Part 1B Dose Expansion - Part 2B
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Cycle 1 (21 Days) Dose-Limiting Toxicities (DLTs) in Part 1A
Timepoint [1] 0 0
First cycle, Day 1 up to Day 21
Primary outcome [2] 0 0
Number of Participants Wth Cycle 1 (28 Days) Dose-Limiting Toxicities (DLTs) in Part 1B
Timepoint [2] 0 0
First Cycle, Day 1 up to Day 28
Primary outcome [3] 0 0
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs), Treatment-Related TEAEs and SAEs
Timepoint [3] 0 0
From the first dose of study treatment up to a minimum of 28 calendar days after the last dose of study treatment (maximum duration between first and last dose: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Primary outcome [4] 0 0
Number of Participants With Laboratory Abnormalities-Hematology
Timepoint [4] 0 0
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Primary outcome [5] 0 0
Number of Participants With Laboratory Abnormalities-Chemistries
Timepoint [5] 0 0
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Primary outcome [6] 0 0
Number of Participants With Laboratory Abnormalities-Urinalysis
Timepoint [6] 0 0
From baseline to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Primary outcome [7] 0 0
Number of Participants With Vital Signs Data Meeting Pre-Defined Criteria
Timepoint [7] 0 0
From baseline up to follow up (at least 28 days and no more than 35 days after discontinuation of treatment), maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B
Primary outcome [8] 0 0
Percentage of Participants With Objective Response in Part 2
Timepoint [8] 0 0
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
Primary outcome [9] 0 0
Duration of Response (DR) in Part 2
Timepoint [9] 0 0
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
Primary outcome [10] 0 0
Progression-Free Survival (PFS) in Part 2
Timepoint [10] 0 0
Baseline, every 6 weeks from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 49.4 weeks)
Primary outcome [11] 0 0
Time to Tumor Progression (TTP) in Part 2
Timepoint [11] 0 0
Baseline, every 6 weeks from the start of treatment until disease progression, death, or withdrawal from treatment (maximum treatment duration: 49.4 weeks)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response in Part 1
Timepoint [1] 0 0
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Secondary outcome [2] 0 0
Duration of Response (DR) in Part 1
Timepoint [2] 0 0
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) in Part 1
Timepoint [3] 0 0
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Secondary outcome [4] 0 0
Time to Tumor Progression (TTP) in Part 1
Timepoint [4] 0 0
Baseline, every 6 weeks (for Part 1A) or every 8 weeks (for Part 1B) from the start of treatment until disease progression, death, or permanent discontinuation of study treatment (maximum treatment duration: 89.3 weeks for Part 1A, 53.7 weeks for Part 1B)
Secondary outcome [5] 0 0
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06804103
Timepoint [5] 0 0
Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (maximum treatment duration: 89.3 weeks for Part 1A, 49.4 weeks for Part 2A, 53.7 weeks for Part 1B)
Secondary outcome [6] 0 0
Number of Participants With HER2 Positivity Based on Tumor Tissue Analysis
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Maximum Observed Concentration (Cmax) of PF-06804103 Antibody-Drug Conjugate (ADC)
Timepoint [7] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [8] 0 0
Terminal Serum Half-Life (t1/2) of PF-06804103 ADC
Timepoint [8] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [9] 0 0
Area Under The Serum Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06804103 ADC
Timepoint [9] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
Secondary outcome [10] 0 0
Area Under the Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06804103 ADC
Timepoint [10] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Secondary outcome [11] 0 0
Clearance (CL) of PF-06804103 ADC
Timepoint [11] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [12] 0 0
Volume of Distribution at Steady State (Vss) of PF-06804103 ADC
Timepoint [12] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Secondary outcome [13] 0 0
Observed Accumulation Ratio (Rac) of PF-06804103 ADC
Timepoint [13] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
Secondary outcome [14] 0 0
Cmax of PF-06804103 Total Antibody
Timepoint [14] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [15] 0 0
t1/2 of PF-06804103 Total Antibody
Timepoint [15] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [16] 0 0
AUCinf of PF-06804103 Total Antibody
Timepoint [16] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
Secondary outcome [17] 0 0
AUCtau of PF-06804103 Total Antibody
Timepoint [17] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Secondary outcome [18] 0 0
CL of PF-06804103 Total Antibody
Timepoint [18] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [19] 0 0
Vss of PF-06804103 Total Antibody
Timepoint [19] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Secondary outcome [20] 0 0
Rac of PF-06804103 Total Antibody
Timepoint [20] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B
Secondary outcome [21] 0 0
Cmax of PF-06380101 Unconjugated Payload
Timepoint [21] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [22] 0 0
Time for Cmax (Tmax) of PF-06380101 Unconjugated Payload
Timepoint [22] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [23] 0 0
t1/2 of PF-06380101 Unconjugated Payload
Timepoint [23] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 & 4 Day 1 for Part 1B
Secondary outcome [24] 0 0
AUCinf of PF-06380101 Unconjugated Payload
Timepoint [24] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1 for Part 1B
Secondary outcome [25] 0 0
AUCtau of PF-06380101 Unconjugated Payload
Timepoint [25] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 4 Day 1 for Part 1B
Secondary outcome [26] 0 0
Rac of PF-06380101 Unconjugated Payload
Timepoint [26] 0 0
Pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose of Cycle 1 & 4 Day 1 for Part 1A; pre-dose, 1, 4, 24, 72, 168 hours post-dose of Cycle 1 Day 1, pre-dose, 1 hour post-dose of Cycle 3 Day 1 for Part 1B

Eligibility
Key inclusion criteria
* HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only)
* HER2 positive and negative breast cancer (Part 2A)
* HER2 negative breast cancer (Part 1B & Part 2B)
* Performance status of 0 or 1
* Adequate bone marrow, kidney and liver function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known CNS disease including, but not limited to, metastases
* History of exposure to certain cumulative doses of anthracyclines
* Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
* Active and clinically significant bacterial, fungal, or viral infection
* Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
* Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2021
Sample size
Target
Accrual to date
Final
95
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Macquarie University - Macquarie Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Italy
State/province [7] 0 0
Lombardia
Country [8] 0 0
Italy
State/province [8] 0 0
MB
Country [9] 0 0
Italy
State/province [9] 0 0
MI
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Gyeonggi-do
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Incheon
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Stavropol Region
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Saint-Petersburg
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.
Trial website
https://clinicaltrials.gov/study/NCT03284723
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03284723