NeoplasmsPhase 1NCT02129205

A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors

A Phase 1 study testing PF-06650808 in people with Neoplasms and Breast Cancer, run by Pfizer at 11 sites in United States.

Terminated

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

Official record

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Trial summary

To assess the safety and tolerability at increasing dose levels of PF-06650808 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, Breast Cancer
What is being tested?: PF-06650808
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 11 sitesUnited States
Study dates: Jun 2014to Jul 2017
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 advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available
Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
Adequate bone marrow, renal and liver function

Who cannot join

Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of starting study treatment
Patients with known symptomatic brain metastases requiring steroids
Prior treatment with a compound of the same mechanism

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
The OSU Investigational Drug Services
Columbus, Ohio, 43210
The OSU Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
The Ohio State University Martha Morehouse Medical Plaza
Columbus, Ohio, 43221
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
UCLA Hematology/Oncology
Los Angeles, California, 90095
Westwood Bowyer Clinic
Los Angeles, California, 90095
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229
Santa Monica - UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404

Other trials in United States

About this study

Official title: A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06650808 IN PATIENTS WITH ADVANCED SOLID TUMORS

Conditions: Neoplasms, Breast Cancer
Being tested: PF-06650808
Keywords: solid tumors, triple negative breast cancer, PF-06650808, Phase 1
Medical subject headings: Neoplasms, Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

PF-06650808Drug
Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
PF-06650808Drug
Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

Study groups in NCT02129205
Study group	Role	What they receive
PF-06650808	Experimental	Not described Receives: Drug: PF-06650808

What is being measured

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

Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)
Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia >=72 hours or platelets<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.
Measured: Day 1 up to Day 21
Percentage of Participants With Objective Response (Part 1 and Part 2)
Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR.
Measured: Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years

Secondary outcomes (13)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: 3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators.
Measured: 3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators.
Measured: 3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)
Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators.
Measured: 3 years
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm).
Measured: 3 years
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101).
Measured: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence.
Measured: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method.
Measured: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Clearance (CL) (Part 1 and Part 2)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1.
Measured: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1
Volume of Distribution at Steady State (Vss) (Part 1 and Part 2)
Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1.
Measured: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel.
Measured: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2)
Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer>=1.88.
Measured: 3 years
Progression Free Survival and Overall Survival (Part 2)
Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population.
Measured: 3 years

Timeline

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

Jun 2014Jul 2017

First posted2 May 2014 (estimated)
Study startJun 2014
Primary completionJul 2017
Study completionJul 2017

Why it stopped: The study was terminated due to a change in sponsor prioritization.

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.
Publications (1)Papers the sponsor has linked to this study.
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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02129205
Sponsor's protocol ID: B7501001
Status last verified: Dec 2018
First submitted: 30 Apr 2014
Last updated: 29 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Rosen LS, Wesolowski R, Baffa R, Liao KH, Hua SY, Gibson BL, Pirie-Shepherd S, Tolcher AW. A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest New Drugs. 2020 Feb;38(1):120-130. doi: 10.1007/s10637-019-00754-y. Epub 2019 Mar 18.
PubMed 30887250

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 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06650808 IN PATIENTS WITH ADVANCED SOLID TUMORS
ClinicalTrials.gov ID: NCT02129205
Acronym / sponsor ID: B7501001
Conditions: Neoplasms, Breast Cancer
Keywords: solid tumors, triple negative breast cancer, PF-06650808, Phase 1
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to a change in sponsor prioritization.
Enrolment: 40 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2014 (actual)
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 2 May 2014 (estimated)
Results: Posted 29 Mar 2019

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-06650808	Experimental	Drug: PF-06650808

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available
Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
Adequate bone marrow, renal and liver function

Key exclusion criteria (3 listed)

Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of starting study treatment
Patients with known symptomatic brain metastases requiring steroids
Prior treatment with a compound of the same mechanism

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-06650808Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.	Drug	PF-06650808
PF-06650808Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.	Drug	PF-06650808

Primary outcome

Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)
Time frame: Day 1 up to Day 21
Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia >=72 hours or platelets<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.
Percentage of Participants With Objective Response (Part 1 and Part 2)
Time frame: Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years
Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR.

13 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Time frame: 3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Time frame: 3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Time frame: 3 years
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)
Time frame: 3 years
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Time frame: 3 years
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Time frame: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Time frame: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Time frame: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Clearance (CL) (Part 1 and Part 2)
Time frame: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1
Volume of Distribution at Steady State (Vss) (Part 1 and Part 2)
Time frame: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Time frame: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4
Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2)
Time frame: 3 years
Progression Free Survival and Overall Survival (Part 2)
Time frame: 3 years

Results and safety

Results posted to the registry on 29 Mar 2019, 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-06650808 0.2 mg/kg (Part 1)	2	1
PF-06650808 0.4 mg/kg (Part 1)	2	2
PF-06650808 0.8 mg/kg (Part 1)	2	2
PF-06650808 1.6 mg/kg (Part 1)	2	2
PF-06650808 2.0 mg/kg (Part 1)	7	4
PF-06650808 2.4 mg/kg (Part 1)	11	7
PF-06650808 3.0 mg/kg (Part 1)	6	2
PF-06650808 3.6 mg/kg (Part 1)	6	4
PF-06650808 4.68 mg/kg (Part 1)	2	0
PF-06650808 2.4mg/kg (Part 2)	0	0

Primary outcome: Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)

Time frame: Day 1 up to Day 21. Count of participants. Unit: Participants

Measure	PF-06650808 0.2 mg/kg (Part 1) n = 2	PF-06650808 0.4 mg/kg (Part 1) n = 2	PF-06650808 0.8 mg/kg (Part 1) n = 2	PF-06650808 1.6 mg/kg (Part 1) n = 2	PF-06650808 2.0 mg/kg (Part 1) n = 7	PF-06650808 2.4 mg/kg (Part 1) n = 11	PF-06650808 3.0 mg/kg (Part 1) n = 6	PF-06650808 3.6 mg/kg (Part 1) n = 6	PF-06650808 4.68 mg/kg (Part 1) n = 2
Yes	0	0	0	0	0	3	2	1	2
No	2	2	2	2	7	8	4	5	0

Population analysed: The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication.

Primary outcome: Percentage of Participants With Objective Response (Part 1 and Part 2)

Time frame: Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PF-06650808 0.2 mg/kg (Part 1) n = 2	PF-06650808 0.4 mg/kg (Part 1) n = 2	PF-06650808 0.8 mg/kg (Part 1) n = 1	PF-06650808 1.6 mg/kg (Part 1) n = 2	PF-06650808 2.0 mg/kg (Part 1) n = 6	PF-06650808 2.4 mg/kg (Part 1) n = 7	PF-06650808 3.0 mg/kg (Part 1) n = 4	PF-06650808 3.6 mg/kg (Part 1) n = 5	PF-06650808 4.68 mg/kg (Part 1) n = 2	PF-06650808 2.4 mg/kg (Part 2) n = 0
Value	0 (0.0 to 84.2)	0 (0.0 to 84.2)	0 (0.0 to 97.5)	0 (0.0 to 84.2)	16.7 (0.4 to 64.1)	14.3 (0.4 to 57.9)	0 (0.0 to 60.2)	20.0 (0.5 to 71.6)	0 (0.0 to 84.2)	–

Population analysed: The analysis population included all participants who received at least 1 dose of study medication and had both baseline and at least 1 post-baseline tumor assessments. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06650808 0.2 mg/kg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
PF-06650808 0.4 mg/kg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
PF-06650808 0.8 mg/kg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
PF-06650808 1.6 mg/kg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
PF-06650808 2.0 mg/kg	1 of 7 (14.3%)	7 of 7 (100%)	1 of 7
PF-06650808 2.4 mg/kg	3 of 11 (27.3%)	11 of 11 (100%)	1 of 11
PF-06650808 3.0 mg/kg	3 of 6 (50%)	6 of 6 (100%)	0 of 6
PF-06650808 3.6 mg/kg	3 of 6 (50%)	6 of 6 (100%)	0 of 6
PF-06650808 4.68 mg/kg	2 of 2 (100%)	2 of 2 (100%)	0 of 2

Limitations and caveats (from the sponsor): The study was prematurely terminated as a business decision prior to the start of the dose expansion stage.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30887250Rosen LS, Wesolowski R, Baffa R, Liao KH, Hua SY, Gibson BL, Pirie-Shepherd S, Tolcher AW. A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest New Drugs. 2020 Feb;38(1):120-130. doi: 10.1007/s10637-019-00754-y. Epub 2019 Mar 18.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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

11 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-06650808 in people with Neoplasms and Breast Cancer, run by Pfizer at 11 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 3 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 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 29 Mar 2019). 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?

Number of Participants With Dose-limiting Toxicities (DLT) (Part 1) (time frame: Day 1 up to Day 21). The study lists 2 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 NCT02129205, which also lists 1 linked publication.

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 29 Mar 2019.