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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tumor Adenoma Adenosarcoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Carcinosarcoma Chondrosarcoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Facial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosarcoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Hemangiosarcoma Histiocytoma Histiocytoma, Malignant Fibrous Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Leiomyosarcoma Liposarcoma Lung Diseases Lung Neoplasms Lymphangiosarcoma Male Urogenital Diseases Mesothelioma Mesothelioma, Cystic Mixed Tumor, Mesodermal Mouth Diseases Mouth Neoplasms Myosarcoma Myxosarcoma Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Adipose Tissue Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Muscle Tissue Neoplasms, Vascular Tissue Osteosarcoma Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Ovarian Diseases Ovarian Neoplasms Pancoast Syndrome Parathyroid Diseases Parathyroid Neoplasms Phyllodes Tumor Pulmonary Sclerosing Hemangioma Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Solitary Pulmonary Nodule Stomatognathic Diseases Thoracic Neoplasms Thyroid Diseases Thyroid Neoplasms Tracheal Diseases Tracheal Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic Arizona, Scottsdale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belinostat

Drug

300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1

Other names: PXD101

5-fluorouracil (5-FU)

Drug

250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.

Other names: 5-FU

Primary outcomes

to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU

Time frame: throughout the study
to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors

Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Valerio Therapeutics

Industry

Registry information

Official study title

A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Dec 19, 2006
Registry last updated: Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting