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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00413322
Other study ID # PXD101-CLN-4
Secondary ID
Status Completed
Phase Phase 1
First received December 18, 2006
Last updated July 7, 2015
Start date September 2005
Est. completion date June 2008

Study information

Verified date July 2015
Source Onxeo
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
belinostat
300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1
5-Fluorouracil (5-FU)
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.

Locations

Country Name City State
United States University of Nebraska Omaha Nebraska
United States Portsmouth Regional Hospital Hematology/Oncology Clinic Portsmouth New Hampshire
United States Mayo Clinic Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Onxeo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU throughout the study Yes
Primary to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors throughout the study No
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