A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors

NCT02462707 | Withdrawn Phase 1

• 1 other identifier: A8641021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• First-cycle Dose Limiting Toxicities

  during the first 28 days from the first dose

Secondary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax)

  0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose

• QTc interval

  from the first dose to the last dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose

• Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

  0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose

• Plasma Decay Half-Life (t1/2)

  0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose

Study Arms (1)

PF-03084014

EXPERIMENTAL

Drug: PF-03084014

Interventions

PF-03084014 DRUG

gamma-secretase inhibitor, formulated in tablets for oral administration containing 10 mg, 50 mg and 100 mg. Patient will receive 80 mg, 100 mg or 150 mg twice daily of PF-03084014 with continuous dosing schedule

PF-03084014

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
• Age ≥18 years.
• ECOG Performance Status (PS) must be 0 or 1.
• Adequate Bone Marrow Function
• Adequate Renal Function
• Adequate Liver Function
• Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

You may not qualify if:

• Patients with known brain metastases
• Major surgery within 4 weeks of starting study treatment
• Radiation therapy within 2 weeks of starting study treatment
• Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
• Previous high dose chemotherapy requiring stem cell rescue
• Prior irradiation to \>25% of the bone marrow
• Prior treatment with a Notch signal inhibitor
• Known malabsorption syndrome or other condition that may impair absorption of study medication
• Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
• Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
• Current use or anticipated need for known strong CYP3A4 inducers

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Interventions

nirogacestat

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 7, 2015

Record last verified: 2015-08