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P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin. This study will test how well the drug is tolerated, and what effects there might be. Blood will also be taken to measure the amount of drug in blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-03732010 | Experimental | Single Arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03732010 | Drug | IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle | |
| Recommended Phase-2 Dose (RP2D) | Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)] | AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day). | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Human Anti-Human Antibody (HAHA) Levels | HAHA are indicators of immunogenicity to PF-03732010. | Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal |
| Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19111 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-03732010 0.5 mg/kg Biweekly | PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| FG001 | PF-03732010 1.0 mg/kg Biweekly | PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| FG002 | PF-3732010 2.0 mg/kg Biweekly | PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| FG003 | PF-03732010 4.0 mg/kg Biweekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| FG004 | PF-03732010 8.0 mg/kg Biweekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| FG005 | PF-03732010 15.0 mg/kg Biweekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| FG006 | PF-03732010 4.0 mg/kg Weekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| FG007 | PF-03732010 8.0 mg/kg Weekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| FG008 | PF-03732010 15.0 mg/kg Weekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-03732010 0.5 mg/kg Biweekly | PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| BG001 | PF-03732010 1.0 mg/kg Biweekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | MTD analysis population included all participants enrolled in the dose escalation part of the study who received at least 1 dose of study medication. | Posted | Number | mg/kg | Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-03732010 0.5 mg/kg Biweekly | PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
Results are not provided because development of the study drug was terminated, as neither anti-tumor activity nor pharmacodynamic modulation was observed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| C556089 | PF-03732010 monoclonal antibody |
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|
| Time to Reach Maximum Observed Serum Concentration (Tmax) | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| Minimum Observed Serum Trough Concentration (Cmin) | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| Maximum Observed Serum Concentration (Cmax) | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)] | AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day). | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| 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). | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| Clearance (CL) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| Apparent Volume of Distribution (Vd) | 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 blood concentration of a drug. | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
| Number of Participants With Objective Response of Complete Response or Partial Response | Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 |
| Baseline, cycle 3 and after 8 weeks |
| Time to Disease Progression | Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first. | Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 |
| Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood | Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal |
| Change From Baseline in Leucocyte Subtypes | Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal |
| Change From Baseline in Cytokine Concentration | Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1 |
| Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC) | Baseline and cycle 3 |
| Parkville |
| Victoria |
| 3050 |
| Australia |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Adverse Event |
|
| Global deterioration of health |
|
| Objective progression or relapse |
|
| Withdrawal by Subject |
|
PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| BG002 | PF-3732010 2.0 mg/kg Biweekly | PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| BG003 | PF-03732010 4.0 mg/kg Biweekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| BG004 | PF-03732010 8.0 mg/kg Biweekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| BG005 | PF-03732010 15.0 mg/kg Biweekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| BG006 | PF-03732010 4.0 mg/kg Weekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| BG007 | PF-03732010 8.0 mg/kg Weekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| BG008 | PF-03732010 15.0 mg/kg Weekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| BG009 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | PF-3732010 2.0 mg/kg Biweekly | PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| OG003 | PF-03732010 4.0 mg/kg Biweekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| OG004 | PF-03732010 8.0 mg/kg Biweekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| OG005 | PF-03732010 15.0 mg/kg Biweekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). |
| OG006 | PF-03732010 4.0 mg/kg Weekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| OG007 | PF-03732010 8.0 mg/kg Weekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
| OG008 | PF-03732010 15.0 mg/kg Weekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). |
|
|
| Primary | Recommended Phase-2 Dose (RP2D) | Data was not analyzed, as development of the compound was terminated. | Posted | Number | mg/kg | Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle |
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)] | AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day). | Data was not summarized, as development of the compound was terminated. | Posted | Geometric Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) | Data was not summarized, as development of the compound was terminated. | Posted | Median | Full Range | hr | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | Minimum Observed Serum Trough Concentration (Cmin) | Data was not summarized, as development of the compound was terminated. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) | Data was not summarized, as development of the compound was terminated. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)] | AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day). | Data was not summarized, as development of the compound was terminated. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | 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). | Data was not summarized, as development of the compound was terminated. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | Clearance (CL) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Data was not summarized, as development of the compound was terminated. | Posted | Geometric Mean | Standard Deviation | Liter/hr | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | Apparent Volume of Distribution (Vd) | 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 blood concentration of a drug. | Data was not summarized, as development of the compound was terminated. | Posted | Geometric Mean | Standard Deviation | Liter | 0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal |
|
|
| Secondary | Number of Participants With Objective Response of Complete Response or Partial Response | Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Data was not analyzed, as antitumor activity was not observed. | Posted | Number | participants | Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 |
|
|
| Other Pre-specified | Human Anti-Human Antibody (HAHA) Levels | HAHA are indicators of immunogenicity to PF-03732010. | Data was not analyzed, as development of the compound was terminated. | Posted | Mean | Standard Deviation | microgram/mL | Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal |
|
|
| Other Pre-specified | Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET) | Data was not analyzed, as development of the compound was terminated. | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | Baseline, cycle 3 and after 8 weeks |
|
|
| Other Pre-specified | Time to Disease Progression | Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first. | Data was not analyzed, as antitumor activity was not observed. | Posted | Median | Full Range | weeks | Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 |
|
|
| Other Pre-specified | Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood | Data was not analyzed, as development of the compound was terminated. | Posted | Number | cells/mL | Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal |
|
|
| Other Pre-specified | Change From Baseline in Leucocyte Subtypes | Data was not analyzed, as development of the compound was terminated. | Posted | Number | cells/mL | Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal |
|
|
| Other Pre-specified | Change From Baseline in Cytokine Concentration | Data was not analyzed, as development of the compound was terminated. | Posted | Mean | Standard Deviation | picogram (pg)/mL | Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1 |
|
|
| Other Pre-specified | Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC) | Data was not analyzed, as development of the compound was terminated. | Posted | Mean | Standard Deviation | pg/mL | Baseline and cycle 3 |
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | PF-03732010 1.0 mg/kg Biweekly | PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). | 0 | 3 | 3 | 3 |
| EG002 | PF-3732010 2.0 mg/kg Biweekly | PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). | 2 | 4 | 4 | 4 |
| EG003 | PF-03732010 4.0 mg/kg Biweekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). | 0 | 3 | 3 | 3 |
| EG004 | PF-03732010 8.0 mg/kg Biweekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). | 0 | 2 | 2 | 2 |
| EG005 | PF-03732010 15.0 mg/kg Biweekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days). | 1 | 3 | 3 | 3 |
| EG006 | PF-03732010 4.0 mg/kg Weekly | PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). | 1 | 3 | 3 | 3 |
| EG007 | PF-03732010 8.0 mg/kg Weekly | PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). | 0 | 5 | 5 | 5 |
| EG008 | PF-03732010 15.0 mg/kg Weekly | PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days). | 4 | 17 | 13 | 17 |
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Tongue paralysis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Penile pain | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.