NeoplasmsPhase 1NCT01891669

A Study Of PF-06263507 In Patients With Advanced Solid Tumors

A Phase 1 study testing PF-06263507 in people with Neoplasms and Carcinoma, Non Small Cell Lung, run by Pfizer at 4 sites in United States.

Terminated

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

Official record

Search all trials

Trial summary

To assess the safety and tolerability at increasing dose levels of PF-06263507 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, Carcinoma, Non Small Cell Lung, Breast Neoplasms
What is being tested?: PF-06263507
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 4 sitesUnited States
Study dates: 8 Aug 2013to 29 Jun 2015
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 which no standard therapy is available.
Performance Status of 0 or 1.
Adequate bone marrow, kidney, liver, and heart function.

Who cannot join

Brain metastases requiring steroids.
Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
Active bacterial, fungal or viral infection.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS

Conditions: Neoplasms, Carcinoma, Non Small Cell Lung, Breast Neoplasms, Ovarian Neoplasms
Being tested: PF-06263507
Keywords: ADC 5T4, PF-06263507, solid tumors, lung cancer, breast cancer, ovarian cancer, cancer, tumors, neoplasm metastasis
Medical subject headings: Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Neoplasm Metastasis

What participants receive

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

PF-06263507Drug
Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.
PF-06263507Drug
Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

Study groups in NCT01891669
Study group	Role	What they receive
Part 1	Experimental	Not described Receives: Drug: PF-06263507

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)
DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Baseline up to Cycle 2 Day 1 (22 days)

Secondary outcomes (13)

Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Measured: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Measured: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Number of Participants With Hematological Test Abnormalities in All Cycles.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.
Measured: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.
Measured: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Number of Participants With Abnormalities in Urine Protein in All Cycles.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.
Measured: Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).
Measured: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.
Number of Participants With Positive Anti-PF-06263507 Antibody
The number of participants with positive anti-PF-06263507 antibody.
Measured: Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication
Number of Participants With Best Overall Response (BOR)
Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Measured: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Objective Response
Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.
Measured: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Overall Survival
Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.
Measured: Baseline to death
Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)
Measured: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)
Measured: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)
Measured: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.

Timeline

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

8 Aug 201329 Jun 2015

First posted3 Jul 2013 (estimated)
Study start8 Aug 2013
Primary completion29 Jun 2015
Study completion29 Jun 2015

Why it stopped: The study was terminated on June 23, 2015 due to the company's change in prioritization for the portfolio and is not due to any safety concerns.

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: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01891669
Sponsor's protocol ID: B4481001
Status last verified: Dec 2018
First submitted: 10 Jun 2013
Last updated: 9 Jan 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

Shapiro GI, Vaishampayan UN, LoRusso P, Barton J, Hua S, Reich SD, Shazer R, Taylor CT, Xuan D, Borghaei H. First-in-human trial of an anti-5T4 antibody-monomethylauristatin conjugate, PF-06263507, in patients with advanced solid tumors. Invest New Drugs. 2017 Jun;35(3):315-323. doi: 10.1007/s10637-016-0419-7. Epub 2017 Jan 9.
PubMed 28070718

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?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS
ClinicalTrials.gov ID: NCT01891669
Acronym / sponsor ID: B4481001
Conditions: Neoplasms, Carcinoma, Non Small Cell Lung, Breast Neoplasms, Ovarian Neoplasms
Keywords: ADC 5T4, PF-06263507, solid tumors, lung cancer, breast cancer, ovarian cancer, cancer, tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated on June 23, 2015 due to the company's change in prioritization for the portfolio and is not due to any safety concerns.
Enrolment: 26 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 8 Aug 2013 (actual)
Primary completion: 29 Jun 2015 (actual)
Study completion: 29 Jun 2015 (actual)
First posted: 3 Jul 2013 (estimated)
Results: Posted 24 Jun 2016

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
Part 1	Experimental	Drug: PF-06263507

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 solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.
Performance Status of 0 or 1.
Adequate bone marrow, kidney, liver, and heart function.

Key exclusion criteria (3 listed)

Brain metastases requiring steroids.
Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
Active 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-06263507Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.	Drug	Part 1
PF-06263507Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.	Drug	Part 1

Primary outcome

Number of Participants With Dose-limiting Toxicities (DLT)
Time frame: Baseline up to Cycle 2 Day 1 (22 days)
DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

13 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Time frame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Time frame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Number of Participants With Hematological Test Abnormalities in All Cycles.
Time frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Time frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Number of Participants With Abnormalities in Urine Protein in All Cycles.
Time frame: Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Time frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.
Number of Participants With Positive Anti-PF-06263507 Antibody
Time frame: Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication
Number of Participants With Best Overall Response (BOR)
Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Objective Response
Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Overall Survival
Time frame: Baseline to death
Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)
Time frame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)
Time frame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)
Time frame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.

Results and safety

Results posted to the registry on 24 Jun 2016, 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-06263507 0.05 mg/kg	2	0
PF-06263507 0.1 mg/kg	2	1
PF-06263507 0.19 mg/kg	2	2
PF-06263507 0.37 mg/kg	2	2
PF-06263507 0.73 mg/kg	2	2
PF-06263507 1.42 mg/kg	2	2
PF-06263507 2.78 mg/kg	2	1
PF-06263507 4.34 mg/kg	6	2
PF-06263507 5.42 mg/kg	3	2
PF-06263507 6.5 mg/kg	3	1

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

Time frame: Baseline up to Cycle 2 Day 1 (22 days). Number. Unit: Participants

Measure	PF-06263507 0.05 mg/kg n = 2	PF-06263507 0.1 mg/kg n = 2	PF-06263507 0.19 mg/kg n = 2	PF-06263507 0.37 mg/kg n = 2	PF-06263507 0.73 mg/kg n = 2	PF-06263507 1.42 mg/kg n = 2	PF-06263507 2.78 mg/kg n = 2	PF-06263507 4.34 mg/kg n = 6	PF-06263507 5.42 mg/kg n = 3	PF-06263507 6.5 mg/kg n = 3
Value	0	0	0	0	0	0	0	1	0	2

Population analysed: All enrolled participants who received at least one dose of study medication.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of treatment/withdrawal. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06263507 0.05 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06263507 0.1 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06263507 0.19 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06263507 0.37 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06263507 0.73 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06263507 1.42 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06263507 2.78 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
PF-06263507 4.34 mg/kg	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
PF-06263507 5.42 mg/kg	0 of 3 (0%)	3 of 3 (100%)	Not reported
PF-06263507 6.5 mg/kg	0 of 3 (0%)	3 of 3 (100%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated prematurely before treatment in Part 2 started due to a business-related decision.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28070718Shapiro GI, Vaishampayan UN, LoRusso P, Barton J, Hua S, Reich SD, Shazer R, Taylor CT, Xuan D, Borghaei H. First-in-human trial of an anti-5T4 antibody-monomethylauristatin conjugate, PF-06263507, in patients with advanced solid tumors. Invest New Drugs. 2017 Jun;35(3):315-323. doi: 10.1007/s10637-016-0419-7. Epub 2017 Jan 9.
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.

Related trials for Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

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

4 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-06263507 in people with Neoplasms and Carcinoma, Non Small Cell Lung, run by Pfizer at 4 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 24 Jun 2016). 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) (time frame: Baseline up to Cycle 2 Day 1 (22 days)). 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 NCT01891669, 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 9 Jan 2019.