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

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

Tracking Information
First Received DateDecember 18, 2006
Last Changed DateJuly 7, 2015
Start DateSeptember 2005
Actual Primary Completion DateMarch 2008
Primary Outcome Measures

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]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Tumor
Intervention
  • Drug: belinostat
  • Drug: 5-Fluorouracil (5-FU)
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment35
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT00413322
Responsible PartySponsor
SponsorOnxeo
Verification DateJuly 2015
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