NeoplasmsPhase 1NCT02659631

PF-06671008 Dose Escalation Study in Advanced Solid Tumors

A Phase 1 study testing PF-06671008 in people with Neoplasms, run by Pfizer at 9 sites in United States.

Terminated

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

Trial summary

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin expression. The study will then expand to look at the selected dose in patients with P-cadherin expressing TNBC, CRC or NSCLC. 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-06671008
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 9 sitesUnited States
Study dates: 28 Apr 2016to 29 Mar 2019
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 tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available
Performance status of 0 or 1
Adequate bone marrow, kidney and liver function

Who cannot join

Known CNS disease including, but not limited to, metastases
Current or history of seizure disorder
History of or active autoimmune disorders
Active bacterial, fungal or viral infection
Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study treatment
Requirement for systemic immune suppressive medication
Grade 2 or greater peripheral neuropathy

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, New York, 10604
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center- Clinical Trials Office
New York, New York, 10017
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York, New York, 10022
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06671008 IN PATIENTS WITH ADVANCED SOLID TUMORS

Conditions: Neoplasms
Being tested: PF-06671008
Keywords: P-cadherin, PF-06671008, solid tumors, lung cancer, breast cancer, colorectal cancer, NSCLC, TNBC, CRC, neoplasms, Triple negative breast cancer, Non-small cell lung cancer
Medical subject headings: Neoplasms, Lung Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

PF-06671008Drug
Dose Escalation Phase - Part 1
PF-06671008Drug
Dose Expansion Phase - Part 2

Study groups in NCT02659631
Study group	Role	What they receive
PF-06671008	Experimental	Not described Receives: Drug: PF-06671008

What is being measured

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

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part 1
DLT was defined as any of the following adverse events occurring in the first cycle of treatment (21 days after the first dose): a) Hematologic: Febrile neutropenia defined as an absolute neutrophil count (ANC) <1.0 x 10^9/L with a single temperature of >38.3°C, or 101°F, or a sustained temperature of >=38°C, or 100.4°F, for more than one hour; b) Non-hematologic: Delay by more than 2 weeks in receiving the next scheduled dose due to persisting treatment related toxicities; c) Any grade 3 or 4 clinically-relevant hematologic or non-hematologic toxicity.
Measured: Baseline through Day 21 (Cycle 1)
Number of Participants With Objective Response (OR) - Part 2
Number of participants with OR based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions.
PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Secondary outcomes (11)

Maximum Serum Concentration (Cmax) of PF-06671008
Maximum serum concentration (Cmax) of PF-06671008 was observed directly from data.
Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Measured: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06671008
Time for Maximum serum concentration (Tmax) of PF-06671008 was observed directly from data as time of first occurrence.
Measured: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Terminal Elimination Half-life (t1/2) of PF-06671008
Terminal elimination half-life (t1/2) of PF-06671008 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Arithmetic mean was not calculated if fewer than 3 participants had reportable parameter values.
Measured: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06671008
Tau refers to the dosing interval, which was 1 week. Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Measured: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Area Under the Curve From Time 0 Extrapolated to Infinity Time (AUCinf) of PF-06671008
AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Measured: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Systemic Clearance (CL) of PF-06671008
Systemic Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Measured: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Apparent Clearance (CL/F) of PF-06671008
Apparent Clearance (CL/F) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arm.
Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Measured: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Number of Participants With OR - Part 1
Number of participants with OR based on assessment of CR or PR according to RECIST v1.1.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions.
PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression, unacceptable toxicity, or up to 24 months
Number of Participants With Progression Free Survival (PFS) - Part 2
The period from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Measured: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 months
Number of Participants With Overall Survival (OS) - Part 2
The period from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Measured: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 months
Number of Participants With Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06671008
ADA against PF-06671008 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.18 was considered positive.
Measured: C1D1 0 hrs, D15 0 hrs, and C2D1 0 hrs, and D1 0 hrs post additional dosings, up to 24 months

Timeline

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

28 Apr 201629 Mar 2019

First posted20 Jan 2016 (estimated)
Study start28 Apr 2016
Primary completion29 Mar 2019
Study completion29 Mar 2019

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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02659631
Sponsor's protocol ID: B7831001
Status last verified: Apr 2020
First submitted: 15 Jan 2016
Last updated: 6 May 2020
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

Harding JJ, Garrido-Laguna I, Chen X, Basu C, Dowlati A, Forgie A, Hooper AT, Kamperschroer C, Max SI, Moreau A, Shannon M, Wong GY, Hong DS. A Phase 1 Dose-Escalation Study of PF-06671008, a Bispecific T-Cell-Engaging Therapy Targeting P-Cadherin in Patients With Advanced Solid Tumors. Front Immunol. 2022 Apr 14;13:845417. doi: 10.3389/fimmu.2022.845417. eCollection 2022.
PubMed 35493516

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 6 May 2020. 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-06671008 IN PATIENTS WITH ADVANCED SOLID TUMORS
ClinicalTrials.gov ID: NCT02659631
Acronym / sponsor ID: B7831001
Conditions: Neoplasms
Keywords: P-cadherin, PF-06671008, solid tumors, lung cancer, breast cancer, colorectal cancer, NSCLC, TNBC
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 28 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 28 Apr 2016 (actual)
Primary completion: 29 Mar 2019 (actual)
Study completion: 29 Mar 2019 (actual)
First posted: 20 Jan 2016 (estimated)
Results: Posted 6 May 2020

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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PF-06671008	Experimental	Drug: PF-06671008

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 tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available
Performance status of 0 or 1
Adequate bone marrow, kidney and liver function

Key exclusion criteria (7 listed)

Known CNS disease including, but not limited to, metastases
Current or history of seizure disorder
History of or active autoimmune disorders
Active bacterial, fungal or viral infection
Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study treatment

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-06671008Dose Escalation Phase - Part 1	Drug	PF-06671008
PF-06671008Dose Expansion Phase - Part 2	Drug	PF-06671008

Primary outcome

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part 1
Time frame: Baseline through Day 21 (Cycle 1)
DLT was defined as any of the following adverse events occurring in the first cycle of treatment (21 days after the first dose): a) Hematologic: Febrile neutropenia defined as an absolute neutrophil count (ANC) <1.0 x 10^9/L with a single temperature of >38.3°C, or 101°F, or a sustained temperature of >=38°C, or 100.4°F, for more than one hour; b) Non-hematologic: Delay by more than 2 weeks in receiving the next scheduled dose due to persisting treatment related toxicities; c) Any grade 3 or 4 clinically-relevant hematologic or non-hematologic toxicity.
Number of Participants With Objective Response (OR) - Part 2
Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Number of participants with OR based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

11 secondary outcomes

Maximum Serum Concentration (Cmax) of PF-06671008
Time frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06671008
Time frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Terminal Elimination Half-life (t1/2) of PF-06671008
Time frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06671008
Time frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Area Under the Curve From Time 0 Extrapolated to Infinity Time (AUCinf) of PF-06671008
Time frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Systemic Clearance (CL) of PF-06671008
Time frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Apparent Clearance (CL/F) of PF-06671008
Time frame: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose
Number of Participants With OR - Part 1
Time frame: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression, unacceptable toxicity, or up to 24 months
Number of Participants With Progression Free Survival (PFS) - Part 2
Time frame: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 months
Number of Participants With Overall Survival (OS) - Part 2
Time frame: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 months
Number of Participants With Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06671008
Time frame: C1D1 0 hrs, D15 0 hrs, and C2D1 0 hrs, and D1 0 hrs post additional dosings, up to 24 months

Results and safety

Results posted to the registry on 6 May 2020, 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-06671008 1.5 ng/kg IV	1	0
PF-06671008 7.5 ng/kg IV	2	0
PF-06671008 20 ng/kg IV	3	0
PF-06671008 50 ng/kg IV	2	0
PF-06671008 100 ng/kg IV	5	0
PF-06671008 200 ng/kg IV	5	2
PF-06671008 300 ng/kg IV	4	3
PF-06671008 400 ng/kg IV	3	0
PF-06671008 200 ng/kg SC	2	0
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV	1	1

Primary outcome: Number of Participants With Dose-Limiting Toxicities (DLTs) - Part 1

Time frame: Baseline through Day 21 (Cycle 1). Count of participants. Unit: Participants

Measure	PF-06671008 1.5 ng/kg IV n = 1	PF-06671008 7.5 ng/kg IV n = 2	PF-06671008 20 ng/kg IV n = 3	PF-06671008 50 ng/kg IV n = 2	PF-06671008 100 ng/kg IV n = 4	PF-06671008 200 ng/kg IV n = 5	PF-06671008 300 ng/kg IV n = 4	PF-06671008 400 ng/kg IV n = 3	PF-06671008 200 ng/kg SC n = 2	PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV n = 1
Value	0	0	0	0	0	0	0	1	0	0

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

Primary outcome: Number of Participants With Objective Response (OR) - Part 2

Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Population analysed: This study was terminated early and Part 2 was not initiated. Data for this outcome measure was not collected.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06671008 1.5 ng/kg IV	0 of 1 (0%)	1 of 1 (100%)	1 of 1
PF-06671008 7.5 ng/kg IV	1 of 2 (50%)	2 of 2 (100%)	2 of 2
PF-06671008 20 ng/kg IV	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
PF-06671008 50 ng/kg IV	2 of 2 (100%)	2 of 2 (100%)	1 of 2
PF-06671008 100 ng/kg IV	4 of 4 (100%)	4 of 4 (100%)	4 of 4
PF-06671008 200 ng/kg IV	4 of 5 (80%)	5 of 5 (100%)	2 of 5
PF-06671008 300 ng/kg IV	3 of 4 (75%)	4 of 4 (100%)	1 of 4
PF-06671008 400 ng/kg IV	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
PF-06671008 200 ng/kg SC	0 of 2 (0%)	2 of 2 (100%)	1 of 2
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35493516Harding JJ, Garrido-Laguna I, Chen X, Basu C, Dowlati A, Forgie A, Hooper AT, Kamperschroer C, Max SI, Moreau A, Shannon M, Wong GY, Hong DS. A Phase 1 Dose-Escalation Study of PF-06671008, a Bispecific T-Cell-Engaging Therapy Targeting P-Cadherin in Patients With Advanced Solid Tumors. Front Immunol. 2022 Apr 14;13:845417. doi: 10.3389/fimmu.2022.845417. eCollection 2022.
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

9 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-06671008 in people with Neoplasms, run by Pfizer at 9 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 7 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 6 May 2020). 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 (DLTs) - Part 1 (time frame: Baseline through Day 21 (Cycle 1)). 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 NCT02659631, 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 6 May 2020.