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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00557505




Registration number
NCT00557505
Ethics application status
Date submitted
12/11/2007
Date registered
14/11/2007
Date last updated
26/03/2012

Titles & IDs
Public title
A Study Of PF-03732010 In Patients With Advanced Solid Tumors
Scientific title
A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03732010 In Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
A9301001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-03732010

Experimental: PF-03732010 - Single Arm study


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [1] 0 0
Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
Primary outcome [2] 0 0
Recommended Phase-2 Dose (RP2D)
Timepoint [2] 0 0
Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle
Secondary outcome [1] 0 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]
Timepoint [1] 0 0
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 outcome [2] 0 0
Time to Reach Maximum Observed Serum Concentration (Tmax)
Timepoint [2] 0 0
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 outcome [3] 0 0
Minimum Observed Serum Trough Concentration (Cmin)
Timepoint [3] 0 0
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 outcome [4] 0 0
Maximum Observed Serum Concentration (Cmax)
Timepoint [4] 0 0
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 outcome [5] 0 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]
Timepoint [5] 0 0
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 outcome [6] 0 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Timepoint [6] 0 0
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 outcome [7] 0 0
Clearance (CL)
Timepoint [7] 0 0
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 outcome [8] 0 0
Apparent Volume of Distribution (Vd)
Timepoint [8] 0 0
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 outcome [9] 0 0
Number of Participants With Objective Response of Complete Response or Partial Response
Timepoint [9] 0 0
Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00557505