Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Tumor

In brief

This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

Key facts

Study ID

NCT00413322

Run by

Valerio Therapeutics

People needed

35

Starts

2005-09-01

Expected to finish

2008-06-01

Last updated by the study team

2015-07-08

Who can join

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

You may qualify if…

• Histologically confirmed solid tumors
• Advanced colorectal cancer or other adenocarcinomas
• Tumor progression after standard chemotherapy, or where none yet approved
• At least one unidimensionally measurable lesion
• Karnofsky performance >= 70%
• Life expectancy of at least 3 months
• Age >= 18 years
• Signed, written Institutional Review Board (IRB)-approved informed consent
• Acceptable liver function:
• Bilirubin <= 1.5 x upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) <= 2.5 x ULN, OR
• AST (SGOT) and ALT (SGPT) <= 5 x ULN if liver metastasis
• Acceptable renal function:
• Serum creatinine within normal limits, OR
• Calculated creatinine clearance of >= 60 mL/min/1.73 m2 for certain patients
• Acceptable hematologic status:
• Absolute neutrophil count (ANC) >= 1500 cells/mm3
• Platelet count >= 100,000 (plt/mm3)
• Hemoglobin >= 9 g/dL
• Urinalysis: No clinically significant abnormalities
• Acceptable coagulation status:
• Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
• For patients on anticoagulation therapy, status within therapeutic range
• For men and women of child-producing potential, use of effective contraception
• Tumors accessible for needle biopsy

You may not qualify if…

• Significant cardiovascular disease.
• A marked baseline prolongation of QT/QTc interval
• Long QT syndrome
• Required use of medication on dosing days that may cause torsade de pointes.
• Infections requiring intravenous (IV) systemic therapy
• Pregnant or nursing women
• Treatment with chemotherapy or investigational therapy < 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin).
• Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry.
• Unwillingness or inability to comply with protocol procedures.
• Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C
• Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• Concurrent use of other investigational agent(s)
• Serious concurrent medical illness

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• University of Nebraska — Omaha, Nebraska, United States
• Portsmouth Regional Hospital Hematology/Oncology Clinic — Portsmouth, New Hampshire, United States

Full record on ClinicalTrials.gov

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