Clinical Trials /

A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

NCT02222922

Description:

To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
  • Official Title: A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647020 In Adult Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: B7661001
  • SECONDARY ID: 2014-003296-36
  • NCT ID: NCT02222922

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
PF-06647020 Q3WPF-06647020 Q3W
fluconazoleDrug-drug interaction (DDI)
PF-06647020 Q2WPF-06647020 Q2W
PF-06647020 combined with AvelumabPF-06647020 combined with Avelumab

Purpose

To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Trial Arms

NameTypeDescriptionInterventions
PF-06647020 Q3WExperimentalInvestigational drug infused over 60 minutes once every 21 days.
  • PF-06647020 Q3W
Drug-drug interaction (DDI)ExperimentalPF-06647020 combined with fluconazole
  • fluconazole
PF-06647020 Q2WExperimentalInvestigational drug infused over 60 minutes once every 14 days (28 day cycle)
  • PF-06647020 Q2W
PF-06647020 combined with AvelumabExperimentalPF-06647020 combined with Avelumab administered by infusion
  • PF-06647020 combined with Avelumab

Eligibility Criteria

        Q2W Inclusion Criteria:

          -  Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior
             lines, or recurrent advanced NSCLC having received 3 or fewer prior lines

          -  Performance Status of 0, 1, or 2

          -  Adequate bone marrow, kidney, and liver function

        Q2W Exclusion Criteria:

          -  OVCA pts excluded with any of the following: non-epithelial, including malignant mixed
             mullerian tumors, unresolved bowel obstruction

          -  Brain metastases requiring steroids

          -  Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
             study treatment start

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

        Q3W Inclusion Criteria:

          -  Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy
             or for whom no standard therapy is available

          -  Performance Status of 0 or 1

          -  Adequate bone marrow, kidney, and liver function

          -  Part 2 includes ovarian cancer, target expressing triple negative breast cancer and
             non small cell lung cancer patients

        Q3W Exclusion Criteria:

          -  OVCA pts excluded with any of the following: non-epithelial, including malignant mixed
             mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease,
             unresolved bowel obstruction

          -  Brain metastases requiring steroids

          -  Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
             study treatment start

          -  Active and clinically significant bacterial, fungal, or viral infection
      
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 (DLT) {Part1}
Time Frame:Day 1 up to Day 21
Safety Issue:
Description:First cycle DLTs in order to determine maximum tolerated dose

Secondary Outcome Measures

Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Systemic Clearance (CL) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Accumulation ratio (Rac) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Time to Reach Maximum Observed Concentration (Tmax) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies
Time Frame:Days 1, 15, 21, and every 21 days thereafter up to 24 months
Safety Issue:
Description:Number of participants with the presence of anti-PF-06647020 antibodies
Measure:Number of participants with objective response (Part 1)
Time Frame:Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Safety Issue:
Description:Number of participants with objective response based on assessment of response rate (RR)
Measure:Number of participants with objective response (Part 2)
Time Frame:Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Safety Issue:
Description:Number of participants with objective response based on assessment of overall response rate (ORR) and progression free survival (PFS)
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06380101 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for PF-06380101 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Systemic Clearance (CL) for PF-06380101 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for PF-06380101 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Accumulation ratio (Rac) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Time to Reach Maximum Observed Concentration (Tmax) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Systemic Clearance (CL) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Accumulation ratio (Rac) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Time to Reach Maximum Observed Concentration (Tmax) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06647020 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for PF-06647020 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for PF-06647020 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for PF-06647020 [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for hu6M024 mAb [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for hu6M024 mAb [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for hu6M024 mAb [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for hu6M024 mAb [DDI sub-study]
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Systemic Clearance (CL) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Accumulation ratio (Rac) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Time to Reach Maximum Observed Concentration (Tmax) for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06647020
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies
Time Frame:Days 1, 15, 28, and every 28 days thereafter up to 24 months
Safety Issue:
Description:Number of participants with the presence of anti-PF-06647020 antibodies
Measure:Number of Q2W participants with objective response (single agent)
Time Frame:Baseline, every 8 weeks until disease progression or unacceptable toxicity up to 24 months
Safety Issue:
Description:Number of participants with objective response based on assessment of response rate (RR)
Measure:Number of combination participants with objective response (PF-06647020 + avelumab)
Time Frame:Baseline, every 8 weeks until disease progression or unacceptable toxicity up to 24 months
Safety Issue:
Description:Number of participants with objective response based on assessment of overall response rate (ORR) and progression free survival (PFS)
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Systemic Clearance (CL) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Accumulation ratio (Rac) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Time to Reach Maximum Observed Concentration (Tmax) for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06380101
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Maximum Observed Concentration (Cmax) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Systemic Clearance (CL) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Terminal half-life (t1/2) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Accumulation ratio (Rac) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Time to Reach Maximum Observed Concentration (Tmax) for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for hu6M024 mAb
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies (avelumab)
Time Frame:Days 1, 15, 28, and every 28 days thereafter up to 24 months
Safety Issue:
Description:Number of participants with the presence of anti-avelumab antibodies

Details

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

Trial Keywords

  • ADC
  • PF-06647020
  • solid tumors
  • tumors
  • neoplasm metastasis
  • TNBC
  • triple negative breast cancer
  • NSCLC
  • non small cell lung cancer
  • advanced metastatic breast cancer
  • ovarian cancer
  • OVCA

Last Updated

April 4, 2018