Clinical Trials /

A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors

NCT02129205

Description:

To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title:A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
  • Official Title:A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of Pf-06650808 In Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: B7501001
  • NCT ID: NCT02129205

Trial Conditions

  • Neoplasms
  • Breast Cancer

Trial Interventions

DrugSynonymsArms
PF-06650808PF-06650808
PF-06650808PF-06650808

Trial Purpose

To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
PF-06650808Experimental
  • PF-06650808
  • PF-06650808

Eligibility Criteria

Inclusion Criteria:

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

- Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion

- Adequate bone marrow, renal and liver function

Exclusion Criteria:

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

- Patients with known symptomatic brain metastases requiring steroids

- Prior treatment with a compound of the same mechanism

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with Dose-Limiting Toxicities (DLT) [Part 1]
Time Frame:Day 1 up to Day 21
Safety Issue:Yes
Description:First cycle DLTs in order to determine maximum tolerated dose

Secondary Outcome Measures

Measure:Maximum Observed Plasma Concentration (Cmax)
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:No
Description:
Measure:Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:No
Description:
Measure:Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:No
Description:
Measure:Systemic Clearance (CL)
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:No
Description:CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measure:Incidence of anti-drug antibodies
Time Frame:Day 1, 15, 21, and every 21 days thereafter up to 24 months
Safety Issue:No
Description:Number of participants with the presence of anti-PF-06650808 antibodies
Measure:Number of participants with objective response, PFS and OS [Part 2]
Time Frame:Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months
Safety Issue:No
Description:
Measure:Volume of Distribution at Steady State (Vss)
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:No
Description: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. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Measure:Plasma Decay Half-Life (t1/2)
Time Frame:Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months
Safety Issue:No
Description:Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Trial Keywords

  • solid tumors
  • triple negative breast cancer
  • PF-06650808
  • Phase 1