NeoplasmsPhase 1NCT00437203

PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

A Phase 1 study testing PF-00477736 and gemcitabine in people with Neoplasms, run by Pfizer at 7 sites in 2 countries.

Terminated

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

Trial summary

To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans. 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-00477736 and gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 7 sitesin 2 countries
Study dates: Dec 2006to Apr 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

Histological or cytopathological diagnosis of solid malignancy that is refractory to standard therapy or for which no curative therapy exists.
ECOG performance status 0 or 1.
Adequate blood cell counts, kidney function and liver function.

Who cannot join

Prior treatment with gemcitabine.
Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.
NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC Grade 3 hypertension that is well controlled.
Known human immunodeficiency virus (HIV) seropositivity.
Concurrent treatment with anticoagulants or known coagulopathy

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States6 sites

Pfizer Investigational Site
Los Angeles, California, 90095-6984
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
New York, New York, 10065
Pfizer Investigational Site
Santa Monica, California, 90403
Pfizer Investigational Site
Santa Monica, California, 90404

Other trials in United States

Australia1 site

Pfizer Investigational Site
East Melbourne, Victoria, 3002

Other trials in Australia

About this study

Official title: Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies

Read the detailed description

The study was closed to enrollment as of 17 May 2010 due to business reasons. The patient on study continued treatment until 19 April 2011 when stopped for complete response. Premature closure was not prompted by any safety or efficacy concerns.

Conditions: Neoplasms
Being tested: PF-00477736, gemcitabine
Keywords: Advanced cancer
Medical subject headings: Neoplasms

What participants receive

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

PF-00477736Drug
- Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).
- If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion.
gemcitabineDrug
gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).

Study groups in NCT00437203
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: PF-00477736; Drug: gemcitabine

What is being measured

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

Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine
Measured: Up to Day 21 Cycle 1

Secondary outcomes (10)

Number of Participants With Objective Response (OR)
OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.
Measured: Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62
Maximum Observed Plasma Concentration (Cmax)
Measured: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Minimum Observed Plasma Trough Concentration (Cmin)
Measured: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
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: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]
AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).
Measured: 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Measured: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Concentration of PF-00477736 in Urine
Measured: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Metabolite Profile of PF-00477736 in Plasma and Urine
Measured: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10

Timeline

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

Dec 2006Apr 2011

First posted19 Feb 2007 (estimated)
Study startDec 2006
Primary completionApr 2011
Study completionApr 2011

Why it stopped: See termination reason in detailed description.

Resources

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

More details

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

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00437203
Sponsor's protocol ID: A8211001
Status last verified: Mar 2012
First submitted: 16 Feb 2007
Last updated: 3 Apr 2012
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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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT00437203
Acronym / sponsor ID: A8211001
Conditions: Neoplasms
Keywords: Advanced cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 43 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 19 Feb 2007 (estimated)
Results: Posted 3 Apr 2012

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: PF-00477736, Drug: gemcitabine

Who may qualify

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

Key inclusion criteria (3 listed)

Histological or cytopathological diagnosis of solid malignancy that is refractory to standard therapy or for which no curative therapy exists.
ECOG performance status 0 or 1.
Adequate blood cell counts, kidney function and liver function.

Key exclusion criteria (6 listed)

Prior treatment with gemcitabine.
Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.
NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC Grade 3 hypertension that is well controlled.
Known human immunodeficiency virus (HIV) seropositivity.

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-00477736* Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts). * If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion.	Drug	1
gemcitabinegemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).	Drug	1

Primary outcome

Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine
Time frame: Up to Day 21 Cycle 1

10 secondary outcomes

Number of Participants With Objective Response (OR)
Time frame: Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]
Time frame: 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Concentration of PF-00477736 in Urine
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Plasma Decay Half-Life (t1/2)
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10
Metabolite Profile of PF-00477736 in Plasma and Urine
Time frame: 0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10

Results and safety

Results posted to the registry on 3 Apr 2012, 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-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	6	0
PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	8	0
PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	3	0
PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	3	0
PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	3	0
PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	3	0
PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	7	0
PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	3	0
PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	3	0
PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	4	0

Primary outcome: Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine

Time frame: Up to Day 21 Cycle 1. Number. Unit: mg

Measure	PF-00477736 + Gemcitabine 750 mg/m^2 n = 36	PF-00477736 + Gemcitabine 1000 mg/m^2 n = 7
Value	270	NA

Population analysed: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study medication.

10 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-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)	3 of 8 (37.5%)	8 of 8 (100%)	Not reported
PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)	0 of 3 (0%)	3 of 3 (100%)	Not reported
PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)	4 of 7 (57.1%)	7 of 7 (100%)	Not reported
PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)	2 of 3 (66.7%)	2 of 3 (66.7%)	Not reported
PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)	0 of 3 (0%)	3 of 3 (100%)	Not reported
PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)	3 of 4 (75%)	3 of 4 (75%)	Not reported

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-00477736 and gemcitabine in people with Neoplasms, run by Pfizer at 7 sites in 2 countries.

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 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: stopped early, as of the sponsor's last update on 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Australia. 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 3 Apr 2012). 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?

Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine (time frame: Up to Day 21 Cycle 1). 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 NCT00437203.

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 3 Apr 2012.