Status:
COMPLETED
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
Lead Sponsor:
Valerio Therapeutics
Conditions:
Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00413322
Start Date
September 1 2005
End Date
June 1 2008
Last Update
July 8 2015
Active Locations (3)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
University of Nebraska
Omaha, Nebraska, United States, 68198-7680
3
Portsmouth Regional Hospital Hematology/Oncology Clinic
Portsmouth, New Hampshire, United States, 03801