A Study Of PF-03732010 In Patients With Advanced Solid Tumors
- Conditions
- Neoplasms
- Interventions
- Drug: PF-03732010
- Registration Number
- NCT00557505
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PF-03732010 PF-03732010 Single Arm study
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (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 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) 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)] 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 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) 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 plasma concentration time-curve from zero to the last measured concentration (AUClast).
Clearance (CL) 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 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) 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 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 Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇰🇷Seoul, Korea, Republic of