Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Sol… (NCT00413322) | Clinical Trial Compass
CompletedPhase 1
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
United States35 participantsStarted 2005-09
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Infec…
What they're measuring
1
to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU
Timeframe: throughout the study
2
to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors