NeoplasmsPhase 1NCT02122146

A Study Of PF-06664178 In Patients With Advanced Solid Tumors

A Phase 1 study testing PF-06664178 in people with Neoplasms, run by Pfizer at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: PF-06664178
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 10 sitesUnited States
Study dates: Aug 2014to Jun 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
Performance Status of 0 or 1
Adequate bone marrow, kidney and liver function
Part 2 includes target expressing NSCLC, ovarian or breast cancer patients

Who cannot join

Brain metastases requiring steroids
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
Active and clinically significant bacterial, fungal, or viral infection

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Anschutz Cancer Pavilion
Aurora, Colorado, 80045
University of Colorado Denver CTO (CTRC)
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
Keck Hospital of USC
Los Angeles, California, 90033
LAC&USC Medical Center
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Swedish Medical Center
Seattle, Washington, 98104
Seattle Cancer Care Alliance
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors

Conditions: Neoplasms
Being tested: PF-06664178
Keywords: ADC, PF-06664178, solid tumors, tumors, neoplasm metastasis, NSCLC, non small cell lung cancer, OVCA, ovarian cancer, Phase 1, breast cancer
Medical subject headings: Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06664178Drug
Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.
PF-06664178Drug
Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.

Study groups in NCT02122146
Study group	Role	What they receive
PF-06664178	Experimental	Experimental Receives: Drug: PF-06664178

What is being measured

The primary outcome is the main question the study is designed to answer.

First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Measured: Day 1 up to Day 21
Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
Measured: Day 1 up to Day 21
Number of Participants With Laboratory Abnormalities [Part 2 & 3]
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.
Measured: On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)

Secondary outcomes (25)

Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
Measured: From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)
Number of Participants With Laboratory Abnormalities[Part 1]
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.
Measured: Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)
Overall Incidence of Anti-PF-06664178-Antibodies[Part 1]
Number of participants with the presence of anti-PF-06664178 antibodies
Measured: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3]
Number of participants with the presence of anti-PF-06664178 antibodies
Measured: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
Overall Number of Participants With Objective Tumor Response[Part 1]
Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline.
Measured: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Overall Number of Participants With Objective Tumor Response [Part 2 & 3]
Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In)
Measured: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3]
Cmax of PF-06664178 was observed directly from data
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3]
Cmax of total antibody PF-06479118 was observed directly from data
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Cmax of unconjugated payload PF-06380101 was observed directly from data
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3]
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3]
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3]
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3]
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3]
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Trop-2 Expression Levels on Archived Tissue [Part 2 & 3]
Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression
Measured: Day 1
Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3]
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
Measured: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jun 2016

First posted24 Apr 2014 (estimated)
Study startAug 2014
Primary completionJun 2016
Study completionJun 2016

Why it stopped: The study was prematurely discontinued due to a business-related decision on 09-FEB-2016. The decision to terminate the trial was based on the overall results.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02122146
Sponsor's protocol ID: B7401001
Other IDs: 2015-002704-84, 2015
Status last verified: Aug 2017
First submitted: 17 Apr 2014
Last updated: 19 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT02122146
Acronym / sponsor ID: B7401001
Conditions: Neoplasms
Keywords: ADC, PF-06664178, solid tumors, tumors, neoplasm metastasis, NSCLC, non small cell lung cancer, OVCA
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was prematurely discontinued due to a business-related decision on 09-FEB-2016. The decision to terminate the trial was based on the overall results.
Enrolment: 31 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2014 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 24 Apr 2014 (estimated)
Results: Posted 19 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PF-06664178	Experimental	Drug: PF-06664178Experimental

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
Performance Status of 0 or 1
Adequate bone marrow, kidney and liver function
Part 2 includes target expressing NSCLC, ovarian or breast cancer patients

Key exclusion criteria (3 listed)

Brain metastases requiring steroids
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
Active and clinically significant bacterial, fungal, or viral infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06664178Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.	Drug	PF-06664178
PF-06664178Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.	Drug	PF-06664178

Primary outcome

First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Time frame: Day 1 up to Day 21
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]
Time frame: Day 1 up to Day 21
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
Number of Participants With Laboratory Abnormalities [Part 2 & 3]
Time frame: On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.

25 secondary outcomes

Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1]
Time frame: From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)
Number of Participants With Laboratory Abnormalities[Part 1]
Time frame: Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)
Overall Incidence of Anti-PF-06664178-Antibodies[Part 1]
Time frame: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3]
Time frame: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
Overall Number of Participants With Objective Tumor Response[Part 1]
Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Overall Number of Participants With Objective Tumor Response [Part 2 & 3]
Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Trop-2 Expression Levels on Archived Tissue [Part 2 & 3]
Time frame: Day 1
Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
Time frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment

Results and safety

Results posted to the registry on 19 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-06664178 0.15 mg/kg	2	1
PF-06664178 0.30 mg/kg	2	1
PF-06664178 0.60 mg/kg	4	2
PF-06664178 1.20 mg/kg	4	3
PF-06664178 2.40 mg/kg	4	3
PF-06664178 3.60 mg/kg	6	5
PF-06664178 4.20 mg/kg	1	0
PF-06664178 4.80 mg/kg	8	6

Primary outcome: First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)

Time frame: Day 1 up to Day 21. Number. Unit: participants

Measure	PF-06664178 0.15 mg/kg n = 2	PF-06664178 0.30 mg/kg n = 2	PF-06664178 0.60 mg/kg n = 4	PF-06664178 1.20 mg/kg n = 4	PF-06664178 2.40 mg/kg n = 4	PF-06664178 3.60 mg/kg n = 6	PF-06664178 4.20 mg/kg n = 1	PF-06664178 4.80 mg/kg n = 8
Yes	0	0	0	0	0	2	1	4
No	2	2	4	4	4	4	0	4

Population analysed: All enrolled participants who started treatment. One of participants that experienced DLTs in PF-06664178 4.80mg/kg group was a late DLT that occurred at the beginning of Cycle 2 and was classified as a late DLT.

Primary outcome: Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]

Time frame: Day 1 up to Day 21

Population analysed: No participant was analyzed due to study termination

Primary outcome: Number of Participants With Laboratory Abnormalities [Part 2 & 3]

Time frame: On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)

Population analysed: No participant was analyzed due to study termination

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06664178 0.15 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06664178 0.30 mg/kg	1 of 2 (50%)	2 of 2 (100%)	Not reported
PF-06664178 0.60 mg/kg	2 of 4 (50%)	4 of 4 (100%)	Not reported
PF-06664178 1.20 mg/kg	0 of 4 (0%)	4 of 4 (100%)	Not reported
PF-06664178 2.40 mg/kg	1 of 4 (25%)	4 of 4 (100%)	Not reported
PF-06664178 3.60 mg/kg	3 of 6 (50%)	6 of 6 (100%)	Not reported
PF-06664178 4.20 mg/kg	1 of 1 (100%)	1 of 1 (100%)	Not reported
PF-06664178 4.80 mg/kg	5 of 8 (62.5%)	8 of 8 (100%)	Not reported
Total	13 of 31 (41.9%)	31 of 31 (100%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated prematurely for business reasons

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06664178 in people with Neoplasms, run by Pfizer at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) (time frame: Day 1 up to Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02122146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.