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

Information source: Onxeo
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor

Intervention: belinostat (Drug); 5-Fluorouracil (5-FU) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Onxeo

Official(s) and/or principal investigator(s):
Topotarget A/S, Study Chair, Affiliation: Onxeo


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).

Clinical Details

Official 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Mayo Clinic Arizona, Scottsdale, Arizona 85259, United States

University of Nebraska, Omaha, Nebraska 68198-7680, United States

Portsmouth Regional Hospital Hematology/Oncology Clinic, Portsmouth, New Hampshire 03801, United States

Additional Information

Starting date: September 2005
Last updated: July 7, 2015

Page last updated: August 20, 2015

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