PTC596 in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Cancer

In brief

This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in patients with advanced cancer.

Key facts

Study ID

NCT02404480

Run by

PTC Therapeutics

People needed

31

Starts

2016-01-01

Expected to finish

2017-02-06

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, for which standard curative measures do not exist, that has progressed on at least one line of standard therapy or for which no standard therapies exists
• Discontinuation of all other therapies (including other investigational drugs, radiotherapy, or chemotherapy) for the treatment of cancer ≥4 weeks (≥6 weeks if nitrosoureas, ≥12 weeks if radiotherapy) before initiation of study treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of at least 3 months
• A measured or estimated creatinine clearance (CrCl) ≥60 mL/min/1.73 m2

You may not qualify if…

• Prior bone marrow/hematopoietic stem cell transplantation
• History of solid organ, bone marrow, or progenitor cell transplantation
• History of major surgical procedure within 28 days prior to start of study treatment
• Evidence of ongoing systemic bacterial, fungal, or viral infection. Known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness
• Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Duke University — Durham, North Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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