NeoplasmPhase 1NCT01105533

A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors

A Phase 1 study testing PF-00337210 in people with Neoplasm, run by Pfizer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasm
What is being tested?: PF-00337210
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 3 sitesUnited States
Study dates: May 2006to Sep 2011
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

Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors [RECIST].
Adequate bone marrow, liver function and renal function as defined by protocol.
Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.
During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.

Who cannot join

Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry
Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
Patients with carcinomatous meningitis or un-treated brain metastases.
Any acute cardiovascular incident within the past 12 months.
Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol
Patients with no evidence of the following for 5 years: malignancy or metastatic disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or T1C prostate cancer.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors

Conditions: Neoplasm
Being tested: PF-00337210
Keywords: VGEF inhibitor, Anti angiogenesis, Advanced Solid Tumors
Medical subject headings: Neoplasms

What participants receive

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

PF-00337210Drug
0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous
PF-00337210Drug
1mg Capsule Once Daily (Dose Escalation) Continuous
PF-00337210Drug
2mg Capsule Once Daily (Dose Escalation) Continuous
PF-00337210Drug
4mg Capsule Once Daily (Dose Escalation) Continuous
PF-00337210Drug
6mg Capsule Once Daily (Dose Escalation) Continuous
PF-00337210Drug
9mg Capsule Once Daily (Dose Escalation) Continuous
PF-00337210Drug
8mg Capsule Once Daily (Dose Escalation) Continuous
PF-00337210Drug
4mg Capsule Twice Daily (Dose Escalation) Continuous
PF-00337210Drug
6mg Capsule Twice Daily (Dose Escalation) Continuous
PF-00337210Drug
6mg Capsule Twice Daily (Dose Expansion) Continuous

Study groups in NCT01105533
Study group	Role	What they receive
Cohort 1	Experimental	Not described Receives: Drug: PF-00337210
Cohort 2	Experimental	Not described Receives: Drug: PF-00337210
Cohort 3	Experimental	Not described Receives: Drug: PF-00337210
Cohort 4	Experimental	Not described Receives: Drug: PF-00337210
Cohort 5	Experimental	Not described Receives: Drug: PF-00337210
Cohort 6	Experimental	Not described Receives: Drug: PF-00337210
Cohort 7	Experimental	Not described Receives: Drug: PF-00337210
Cohort 8	Experimental	Not described Receives: Drug: PF-00337210
Cohort 9	Experimental	Not described Receives: Drug: PF-00337210
Cohort 10	Experimental	Not described Receives: Drug: PF-00337210

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)
DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.
Measured: Baseline up to Day 28
Maximum Tolerated Dose (MTD)
MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.
Measured: Day 28
Maximum Administered Dose (MAD)
MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.
Measured: Day 28
Recommended Phase-2 Dose (RP2D)
RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing.
Measured: Day 28

Secondary outcomes (8)

Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]
AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).
Measured: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Apparent Volume of Distribution (Vss)
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 plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.
Measured: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Number of Participants With Objective Response of Complete Response or Partial Response
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions and no appearance of new lesions. Confirmed PR defined as at least 30 percent decrease in sum of the longest dimensions (LD) of the target lesions, taking as a reference the baseline sum LD, without progression of non-target lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
Measured: Baseline, every 8 weeks up to Cycle 25 (Week 100)
Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25
Biomarkers included soluble plasma proteins associated with angiogenesis (vascular endothelial growth factor [VEGF], soluble vascular endothelial growth factor-2 receptor [sVEGFR2], soluble vascular endothelial growth factor-3 receptor [sVEGFR3], soluble beta type platelet-derived growth factor [sPDGFR beta]) and tumor proliferation (soluble stem-cell factor receptor [sKIT])
Measured: Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25

Timeline

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

May 2006Sep 2011

First posted16 Apr 2010 (estimated)
Study startMay 2006
Primary completionOct 2010
Study completionSep 2011

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 NeoplasmStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01105533
Sponsor's protocol ID: A8051001
Status last verified: Feb 2013
First submitted: 14 Apr 2010
Last updated: 19 Mar 2013
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01105533
Acronym / sponsor ID: A8051001
Conditions: Neoplasm
Keywords: VGEF inhibitor, Anti angiogenesis, Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: University of Wisconsin, Madison
Study start: May 2006
Primary completion: Oct 2010 (actual)
Study completion: Sep 2011 (actual)
First posted: 16 Apr 2010 (estimated)
Results: Posted 19 Mar 2013

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Cohort 1	Experimental	Drug: PF-00337210
Cohort 2	Experimental	Drug: PF-00337210
Cohort 3	Experimental	Drug: PF-00337210
Cohort 4	Experimental	Drug: PF-00337210
Cohort 5	Experimental	Drug: PF-00337210
Cohort 6	Experimental	Drug: PF-00337210
Cohort 7	Experimental	Drug: PF-00337210
Cohort 8	Experimental	Drug: PF-00337210
Cohort 9	Experimental	Drug: PF-00337210
Cohort 10	Experimental	Drug: PF-00337210

Who may qualify

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

Key inclusion criteria (5 listed)

Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors [RECIST].
Adequate bone marrow, liver function and renal function as defined by protocol.
Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.
During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.

Key exclusion criteria (6 listed)

Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry
Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
Patients with carcinomatous meningitis or un-treated brain metastases.
Any acute cardiovascular incident within the past 12 months.
Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol

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-003372100.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous	Drug	Cohort 1
PF-003372101mg Capsule Once Daily (Dose Escalation) Continuous	Drug	Cohort 2
PF-003372102mg Capsule Once Daily (Dose Escalation) Continuous	Drug	Cohort 3
PF-003372104mg Capsule Once Daily (Dose Escalation) Continuous	Drug	Cohort 4
PF-003372106mg Capsule Once Daily (Dose Escalation) Continuous	Drug	Cohort 5
PF-003372109mg Capsule Once Daily (Dose Escalation) Continuous	Drug	Cohort 6
PF-003372108mg Capsule Once Daily (Dose Escalation) Continuous	Drug	Cohort 7
PF-003372104mg Capsule Twice Daily (Dose Escalation) Continuous	Drug	Cohort 8
PF-003372106mg Capsule Twice Daily (Dose Escalation) Continuous	Drug	Cohort 9
PF-003372106mg Capsule Twice Daily (Dose Expansion) Continuous	Drug	Cohort 10

Primary outcome

Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Baseline up to Day 28
DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.
Maximum Tolerated Dose (MTD)
Time frame: Day 28
MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.
Maximum Administered Dose (MAD)
Time frame: Day 28
MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.
Recommended Phase-2 Dose (RP2D)
Time frame: Day 28
RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing.

8 secondary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Plasma Decay Half-Life (t1/2)
Time frame: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]
Time frame: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Apparent Volume of Distribution (Vss)
Time frame: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Systemic Clearance (CL)
Time frame: Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Number of Participants With Objective Response of Complete Response or Partial Response
Time frame: Baseline, every 8 weeks up to Cycle 25 (Week 100)
Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25
Time frame: Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25

Results and safety

Results posted to the registry on 19 Mar 2013, 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-00337210 0.67 mg Once Daily	1	0
PF-00337210 1 mg Once Daily	1	0
PF-00337210 2 mg Once Daily	3	0
PF-00337210 4 mg Once Daily	3	0
PF-00337210 6 mg Once Daily	7	0
PF-00337210 8 mg Once Daily	7	0
PF-00337210 9 mg Once Daily	8	0
PF-00337210 4 mg Twice Daily	4	0
PF-00337210 6 mg Twice Daily	12	0

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

Time frame: Baseline up to Day 28. Number. Unit: participants

Measure	PF-00337210 0.67 mg Once Daily n = 1	PF-00337210 1 mg Once Daily n = 1	PF-00337210 2 mg Once Daily n = 3	PF-00337210 4 mg Once Daily n = 3	PF-00337210 6 mg Once Daily n = 6	PF-00337210 8 mg Once Daily n = 6	PF-00337210 9 mg Once Daily n = 5	PF-00337210 4 mg Twice Daily n = 4	PF-00337210 6 mg Twice Daily n = 12
Value	0	0	0	0	0	0	2	0	1

Population analysed: Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Maximum Tolerated Dose (MTD)

Time frame: Day 28. Number. Unit: mg once daily

Measure	PF-00337210 n = 46
Value	8

Population analysed: Safety analysis set included all enrolled participants who received at least 1 dose of study medication.

Primary outcome: Maximum Administered Dose (MAD)

Time frame: Day 28. Number. Unit: mg once daily

Measure	PF-00337210 n = 46
Value	9

Population analysed: Safety analysis set included all enrolled participants who received at least 1 dose of study medication.

Primary outcome: Recommended Phase-2 Dose (RP2D)

Time frame: Day 28. Number. Unit: mg twice daily

Measure	PF-00337210 n = 46
Value	6

Population analysed: Safety analysis set included all enrolled participants who received at least 1 dose of study medication.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-00337210	19 of 46 (41.3%)	46 of 46 (100%)	Not reported

Limitations and caveats (from the sponsor): Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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

3 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-00337210 in people with Neoplasm, run by Pfizer at 3 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 Mar 2013). 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) (time frame: Baseline up to Day 28). The study lists 4 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 NCT01105533.

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 Mar 2013.