NCT00413322

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

December 18, 2006

Last Update Submit

July 7, 2015

Conditions

Tumor

Keywords

Advanced Solid tumorAdenosarcomaAndrogen-independent prostate cancerbelinostatbladder cancerbladder neoplasmsBreast cancerCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCarcinoma, Small CellCarcinosarcomaChondrosarcomaCoin Lesion, Pulmonarycolorectal cancerEsophageal NeoplasmsFacial NeoplasmsFibrosarcomahead and neck cancerHemangiosarcomaHistiocytoma, Malignant Fibrouskidney cancerLeiomyosarcomaLiposarcomalung cancerlung neoplasmsLymphangiosarcomamesotheliomamesothelioma, cysticMixed Tumor, MesodermalMouth NeoplasmsMyosarcomaMyxosarcomaOsteosarcomaOtorhinolaryngologic NeoplasmsOvarian cancerPancoast's SyndromeParathyroid NeoplasmsPhyllodes TumorPulmonary Sclerosing Hemangiomasarcomathyroid cancerThyroid NeoplasmsTracheal NeoplasmsPXD101

Outcome Measures

Primary Outcomes (2)

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

    throughout the study

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

    throughout the study

Study Arms (1)

Single-arm dose escalation

EXPERIMENTAL
Drug: belinostatDrug: 5-Fluorouracil (5-FU)

Interventions

belinostatDRUG

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

Also known as: PXD101
Single-arm dose escalation
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.

Also known as: 5-FU
Single-arm dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +10 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

University of Nebraska

Omaha, Nebraska, 68198-7680, United States

Location

Portsmouth Regional Hospital Hematology/Oncology Clinic

Portsmouth, New Hampshire, 03801, United States

Location

MeSH Terms

Conditions

NeoplasmsAdenosarcomaUrinary Bladder NeoplasmsBreast NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCarcinoma, Small CellCarcinosarcomaChondrosarcomaSolitary Pulmonary NoduleColorectal NeoplasmsEsophageal NeoplasmsFacial NeoplasmsFibrosarcomaHead and Neck NeoplasmsHemangiosarcomaHistiocytoma, Malignant FibrousKidney NeoplasmsLeiomyosarcomaLiposarcomaLung NeoplasmsLymphangiosarcomaMesotheliomaMesothelioma, CysticMixed Tumor, MesodermalMouth NeoplasmsMyosarcomaMyxosarcomaOsteosarcomaOtorhinolaryngologic NeoplasmsOvarian NeoplasmsPancoast SyndromeParathyroid NeoplasmsPhyllodes TumorPulmonary Sclerosing HemangiomaSarcomaThyroid NeoplasmsTracheal Neoplasms

Interventions

belinostatFluorouracil

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasms, Connective and Soft TissueUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Connective TissueIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEsophageal DiseasesNeoplasms, Fibrous TissueNeoplasms, Vascular TissueHistiocytomaKidney DiseasesNeoplasms, Muscle TissueNeoplasms, Adipose TissueNeoplasm, Lymphatic TissueAdenomaNeoplasms, MesothelialMouth DiseasesStomatognathic DiseasesNeoplasms, Bone TissueOtorhinolaryngologic DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersParathyroid DiseasesThyroid DiseasesTracheal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Topotarget A/S

    Valerio Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

September 1, 2005

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

US(3)