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

Valerio Therapeutics

Status and phase

Completed

Phase 1

Conditions

Tumor

Treatments

Drug: belinostat

Drug: 5-Fluorouracil (5-FU)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413322

PXD101-CLN-4

Details and patient eligibility

About

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).

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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