Overview

This trial is active, not recruiting.

Conditions neoplasms, breast cancer
Treatments pf-06650808
Phase phase 1
Sponsor Pfizer
Start date June 2014
End date November 2016
Trial size 55 participants
Trial identifier NCT02129205, B7501001

Summary

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.

United States New York
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
pf-06650808
Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
pf-06650808
Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

Primary Outcomes

Measure
Number of participants with Dose-Limiting Toxicities (DLT) [Part 1]
time frame: Day 1 up to Day 21
Number of participants with objective response [Part 2]
time frame: Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months

Secondary Outcomes

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
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
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
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
Incidence of anti-drug antibodies
time frame: Day 1, 15, 21, and every 21 days thereafter up to 24 months
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
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of Pf-06650808 In Patients With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.