Clinical Trials /

PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

NCT03284723

Description:

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at the selected dose in patients with breast cancer, gastric cancer and non-small cell lung cancer

Related Conditions:
  • Breast Carcinoma
  • Gastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: PF-06804103 Dose Escalation in HER2 Positive Solid Tumors
  • Official Title: A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of Pf-06804103 In Patients With Human Epidermal Growth Factor Receptor 2 (her2) Positive Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: C0541001
  • SECONDARY ID: 2017-002538-22
  • NCT ID: NCT03284723

Conditions

  • Breast Neoplasms
  • Stomach Neoplasms
  • Esophagogastric Junction Neoplasm
  • Carcinoma, Non-small-cell Lung

Interventions

DrugSynonymsArms
PF-06804103PF-06804103
PF-06804103PF-06804103

Purpose

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at the selected dose in patients with breast cancer, gastric cancer and non-small cell lung cancer

Trial Arms

NameTypeDescriptionInterventions
PF-06804103ExperimentalStudy Treatment
  • PF-06804103
  • PF-06804103

Eligibility Criteria

        Inclusion Criteria:

          -  HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or
             for which no standard therapy is available

          -  Performance status of 0 or 1

          -  Adequate bone marrow, kidney and liver function

        Exclusion Criteria:

          -  Known CNS disease including, but not limited to, metastases

          -  History of exposure to certain cumulative doses of anthracyclines

          -  Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy

          -  Active and clinically significant bacterial, fungal, or viral infection

          -  Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA

          -  Patients with previous history or active interstitial lung disease or pulmonary
             fibrosis, or a history of other clinically significant lung diseases
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with Dose-Limiting Toxicities (DLTs)
Time Frame:Baseline through Day 21
Safety Issue:
Description:First cycle DLTs in order to determine the maximum tolerated dose

Secondary Outcome Measures

Measure:Maximum Observed Concentration (Cmax)
Time Frame:Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Safety Issue:
Description:
Measure:Time to reach maximum observed concentration (Tmax)
Time Frame:Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Safety Issue:
Description:
Measure:Incidence and titers of anti-drug antibodies
Time Frame:Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (each cycle is 21 days) up to 24 months
Safety Issue:
Description:
Measure:Incidence and titers of neutralizing antibodies
Time Frame:Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (each cycle is 21 days) up to 24 months
Safety Issue:
Description:
Measure:Number of participant with objective response
Time Frame:Baseline and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months
Safety Issue:
Description:
Measure:Number of patients with progression free survival
Time Frame:Baseline and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months
Safety Issue:
Description:
Measure:HER2 expression level in patients with documented anti-tumor activity
Time Frame:Baseline and Cycle 3 Day 1 (each cycle is 21 days)
Safety Issue:
Description:
Measure:Area under the curve from time zero to end of dosing interval (AUCtau)
Time Frame:Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Safety Issue:
Description:
Measure:Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast)
Time Frame:Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • HER2
  • PF-06804103
  • ADC
  • breast cancer
  • gastric cancer
  • esophagogastric cancer
  • non-small cell lung cancer
  • neoplasms
  • solid tumors
  • human epidermal growth receptor 2

Last Updated

December 12, 2017