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

Advanced Solid Tumors Clinical Trial

Official title:

Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02462707
• Other study ID #: A8641021
• Status: Withdrawn
• Phase: Phase 1
• First received: June 2, 2015
• Last updated: October 6, 2015
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• PF-03084014
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First-cycle Dose Limiting Toxicities		during the first 28 days from the first dose	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose	No
Secondary	QTc interval		from the first dose to the last dose	Yes
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose	No
Secondary	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	No
Secondary	Plasma Decay Half-Life (t1/2)		0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose	No
Secondary	Apparent Oral Clearance (CL/F)		0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose	No
Secondary	Apparent Volume of Distribution at steady state (Vss/F)		0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin)		0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose	No
Secondary	Average Serum Concentration at steady state (Cav)		0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose	No
Secondary	Accumulation Ratio (Rac)		0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21	No