A Study Of PF-03732010 In Patients With Advanced Solid Tumors

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00557505

First received: November 12, 2007

Last updated: February 21, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2007

Last Updated Date

February 21, 2012

Start Date ^ICMJE

December 2007

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose (MTD) [ Time Frame: Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle ] [ Designated as safety issue: Yes ]
Recommended Phase-2 Dose (RP2D) [ Time Frame: Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03732010 administered in patients with advanced solid tumors.

Change History

Complete list of historical versions of study NCT00557505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)] [ Time Frame: 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 ] [ Designated as safety issue: No ]
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).
Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Minimum Observed Serum Trough Concentration (Cmin) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Maximum Observed Serum Concentration (Cmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)] [ Time Frame: 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 ] [ Designated as safety issue: No ]
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).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Clearance (CL) [ Time Frame: 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 ] [ Designated as safety issue: No ]
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.
Apparent Volume of Distribution (Vd) [ Time Frame: 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 ] [ Designated as safety issue: No ]
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.
Number of Participants With Objective Response of Complete Response or Partial Response [ Time Frame: Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

To establish the safety profile of single-agent PF-03732010
To evaluate pharmacokinetics (PK) of PF-03732010
To evaluate the immunogenicity of PF-03732010
To assess effects of PF-03732010 on biomarkers, on an exploratory basis
To document any preliminary evidence of anti-tumor activity

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study Of PF-03732010 In Patients With Advanced Solid Tumors

Official Title ^ICMJE

A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03732010 In Patients With Advanced Solid Tumors

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neoplasms

Intervention ^ICMJE

Drug: PF-03732010

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.

Study Arm (s)

Experimental: PF-03732010

Single Arm study

Intervention: Drug: PF-03732010

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Advanced solid tumors refractory to (or intolerant of) established therapy known to provide clinical benefit, or for which there is no standard therapy
Age >= 18 years of age
Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1500/uL, hemoglobin ≥ 9 g/dL, platelets > 100,000/uL
Adequate liver function as defined by: bilirubin < 1.5 x ULN, AST, ALT and ALP < 2.5 x ULN, or < 5 x ULN with documented liver and/or bone metastases
Serum creatinine < 1.5 x ULN
ECOG status 0-1
Availability of biopsy tumor tissue (or fine needle aspirate) for testing of P-cadherin expression
Tumor tissue (or fine needle aspirate) showing over-expression of P-cadherin
Must be able to give written informed consent
Be able to comply with scheduled study visits, treatment plans, laboratory tests and other procedures

Exclusion Criteria:

Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of study entry
Patients with carcinomatous meningitis or untreated brain metastases.
History of significant low platelet count, and/or bleeding disorders, requiring medical or surgical intervention
History of significant bleeding episodes within 6 months, unless the source of bleeding has been resected

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00557505

Other Study ID Numbers ^ICMJE

A9301001

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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