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

21 februari 2012 uppdaterad av: Pfizer

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

43

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • Victoria
      • Parkville, Victoria, Australien, 3050
        • Pfizer Investigational Site
  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19111
        • Pfizer Investigational Site
  • Korea, Republiken av
      • Seoul, Korea, Republiken av, 110-744
        • Pfizer Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: PF-03732010
Single Arm study
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Maximum Tolerated Dose (MTD)
Tidsram: Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
Recommended Phase-2 Dose (RP2D)
Tidsram: Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle
Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]
Tidsram: 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).
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
Time to Reach Maximum Observed Serum Concentration (Tmax)
Tidsram: 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
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)
Tidsram: 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
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)
Tidsram: 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
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)]
Tidsram: 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).
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)
Tidsram: 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).
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)
Tidsram: 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.
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)
Tidsram: 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.
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
Tidsram: 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.
Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Human Anti-Human Antibody (HAHA) Levels
Tidsram: 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
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)
Tidsram: Baseline, cycle 3 and after 8 weeks
Baseline, cycle 3 and after 8 weeks
Time to Disease Progression
Tidsram: Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37
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
Tidsram: 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
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
Tidsram: Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal
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
Tidsram: Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1
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)
Tidsram: Baseline and cycle 3
Baseline and cycle 3

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2007

Primärt slutförande (Faktisk)

1 februari 2011

Avslutad studie (Faktisk)

1 februari 2011

Studieregistreringsdatum

Först inskickad

12 november 2007

Först inskickad som uppfyllde QC-kriterierna

12 november 2007

Första postat (Uppskatta)

14 november 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 mars 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 februari 2012

Senast verifierad

1 februari 2012

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • A9301001

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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