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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03284723
Ethics application status
Date submitted
1/09/2017
Date registered
15/09/2017
Date last updated
6/04/2021

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 Dose-Limiting Toxicities (DLTs) - First cycle DLTs in order to determine the maximum tolerated dose of monotherapy.
Timepoint [1] 0 0
Part 1A: Baseline through Day 21; Part 1B: Baseline through Day 28
Primary outcome [2] 0 0
Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) - Assessment of all available safety data in order to determine the safety and tolerability of monotherapy and combination therapy
Timepoint [2] 0 0
Part 1 and Part 2: Baseline through LSLV (up to approximately 2 years)
Primary outcome [3] 0 0
Number of participant with objective response - To investigate preliminary antitumor activity
Timepoint [3] 0 0
Part 2: Baseline through LSLV (up to approximately 2 years)
Primary outcome [4] 0 0
Duration of Response (DR) - To investigate preliminary antitumor activity
Timepoint [4] 0 0
Part 2: Baseline through LSLV (up to approximately 2 years)
Primary outcome [5] 0 0
Progression-Free Survival (PFS) - To investigate preliminary antitumor activity
Timepoint [5] 0 0
Part 2: Baseline through LSLV (up to approximately 2 years)
Primary outcome [6] 0 0
Time to Tumor Progression (TTP) - To investigate preliminary antitumor activity
Timepoint [6] 0 0
Part 2: Baseline through LSLV (up to approximately 2 years)
Secondary outcome [1] 0 0
Maximum Observed Concentration (Cmax) - Part 1A - To understand single and multiple dose parameters
Timepoint [1] 0 0
Cycle 1 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Secondary outcome [2] 0 0
Maximum Observed Concentration (Cmax) - Part 2A - To understand single and multiple dose parameters
Timepoint [2] 0 0
Cycles 1 & 4 on Day 1 at 0, 1, 4 hours, and on Day 15; Cycles 2 & 3 on Day 1 at 0 & 1 hour; Every subsequent cycle pn Day 1 at 0 and 1 hour (cycle is 21 days) up to 24 months
Secondary outcome [3] 0 0
Maximum Observed Concentration (Cmax) Part B - To understand single and multiple dose parameters
Timepoint [3] 0 0
Cycles 1 & 4 on Day 1 at 0, 1, 4, & 24 hours, Day 4, Day 8 & Day 15 at 0 & 1 hour; Cycles 2 & 3 on Day 1 at 0 & 1 hour, Cycles 2 & 3 on Day 15 at 0 & 1 hour; Every subsequent cycle on Day 1 at 0 & 1 hour (cycle is 28 days) up to 24 months
Secondary outcome [4] 0 0
Time to reach maximum observed concentration (Tmax) - Part 1A - To understand single and multiple dose parameters
Timepoint [4] 0 0
Cycles 1 & 4 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycles 2 & 3 Day 1: 0 and 1 hour, and Day 1: 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Secondary outcome [5] 0 0
Time to reach maximum observed concentration (Tmax) - Part 2A - To understand single and multiple dose parameters
Timepoint [5] 0 0
Cycles 1 & 4 on Day 1 at 0, 1, 4 hours, and on Day 15; Cycles 2 & 3 on Day 1 at 0 & 1 hour; Every subsequent cycle pn Day 1 at 0 and 1 hour (cycle is 21 days) up to 24 months
Secondary outcome [6] 0 0
Time to reach maximum observed concentration (Tmax) - Part B - To understand single and multiple dose parameters
Timepoint [6] 0 0
Cycles 1 & 4 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycles 2 & 3 Day 1: 0 and 1 hour, and Day 1: 0 and 1 hour of subsequent cycles (cycle is 28 days) up to 24 months
Secondary outcome [7] 0 0
Area under the curve from time zero to end of dosing interval (AUCtau) Part 1A - To understand single and multiple dose parameters
Timepoint [7] 0 0
Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Secondary outcome [8] 0 0
Area under the curve from time zero to end of dosing interval (AUCtau) Part 2A - To understand single and multiple dose parameters
Timepoint [8] 0 0
Cycles 1 and 4: Day 1: 0, 1, 4 hours, and Day 15; Cycle 2 and 3, Day 1: 0 and 1 hour, and Day 1 at 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Secondary outcome [9] 0 0
Area under the curve from time zero to end of dosing interval (AUCtau) Part B - To understand single and multiple dose parameters
Timepoint [9] 0 0
Cycles 1 and 4: Day 1: 0, 1, 4 hours, Day 2, Day 4, Day 8 and Day 15 at 0 and 1 hour; Cycle 2 and 3, Day 1: 0 and 1 hour and Day 15 at 0 and 1 hour, and Day 1 at 0 and 1 hour of subsequent cycles (cycle is 28 days) up to 24 months
Secondary outcome [10] 0 0
Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 1A - To understand single and multiple dose parameters
Timepoint [10] 0 0
Cycle 1 & Cycle 4 Day 1: 0, 1, 4, & 24 hours, Day 4, Day 8 & Day 15, Cycles 2 & 3 Day 1: 0 & 1 hour, and Day 1 at 0 & 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Secondary outcome [11] 0 0
Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 2A - To understand single and multiple dose parameters
Timepoint [11] 0 0
Cycle 1 & Cycle 4 Day 1: 0, 1, 4 hours, & Day 15, Cycles 2 & 3 Day 1: 0 & 1 hour, and Day 1 at 0 & 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Secondary outcome [12] 0 0
Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part B - To understand single and multiple dose parameters
Timepoint [12] 0 0
Cycle 1 & Cycle 4 Day 1: 0, 1, 4, & 24 hours, Day 4, Day 8 & Day 15, Cycles 2 & 3 Day 1: 0 & 1 hour, and Day 1 at 0 & 1 hour of subsequent cycles (cycle is 28 days) up to 24 months
Secondary outcome [13] 0 0
Incidence and titers of anti-drug antibodies Part A - To evaluate the immunogenicity of the drug
Timepoint [13] 0 0
Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsequent cycle (each cycle is 21 days) up to 24 months
Secondary outcome [14] 0 0
Incidence and titers of anti-drug antibodies Part B - To evaluate the immunogenicity of the drug
Timepoint [14] 0 0
Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 28 days) up to 24 months
Secondary outcome [15] 0 0
Incidence and titers of neutralizing antibodies Part A - To evaluate the immunogenicity of the drug
Timepoint [15] 0 0
Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 21 days) up to 24 months
Secondary outcome [16] 0 0
Incidence and titers of neutralizing antibodies Part B - To evaluate the immunogenicity of the drug
Timepoint [16] 0 0
Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 28 days) up to 24 months
Secondary outcome [17] 0 0
Number of participant with objective response - Document antitumor activity
Timepoint [17] 0 0
Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months
Secondary outcome [18] 0 0
Progression-Free Survival (PFS) - Document antitumor activity
Timepoint [18] 0 0
Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months
Secondary outcome [19] 0 0
HER2 expression level in patients with documented anti-tumor activity - Explore preliminary antitumor activity
Timepoint [19] 0 0
Baseline and Cycle 3 Day 1 (for monotherapy: each cycle is 21 days; for combination therapy: each cycle is 28 days)
Secondary outcome [20] 0 0
Duration of Response (DR) - Document antitumor activity
Timepoint [20] 0 0
Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months
Secondary outcome [21] 0 0
Time to Tumor Progression (TTP) - Document antitumor activity
Timepoint [21] 0 0
Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 University
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
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
MB
Country [8] 0 0
Italy
State/province [8] 0 0
MI
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Stavropol Region
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Saint-Petersburg
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
Spain
State/province [14] 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/show/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
Other publications