Phase I Clinical Trial of 5-Fluoro-Pyrimidinone (5FP), an Oral Prodrug of 5-Fluorouracil (5FU)

LoRusso, Patricia; Prakash, Sucharu; Wozniak, A.; Flaherty, Lawrence E.; Zalupski, Mark M.; Shields, Anthony F.; Sands, Howard; Parchment, Ralph E.; Jasti, Bhaskara

doi:10.1023/a:1014430216434

Cited by 9 publications

(2 citation statements)

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“…Five clinical trials (5-fluoro-pyrimidinone, XK-469, SR271425, BMS247550, KRN5500) were conducted utilizing the AT design (Alousi et al, 2007; Gadgeel et al, 2003, 2005; LoRusso et al, 2002;?). Four of five agents (XK-469, SR271425, BMS247550, KRN5500) were administered intravenously using the 2B design, and the remaining agent (5-fluoro-pyrimidinone) was administered orally using the 4B design.…”

Section: Methodsmentioning

confidence: 99%

Theoretical and Practical Application of Traditional and Accelerated Titration Phase I Clinical Trial Designs: The Wayne State University Experience

Heath

LoRusso

Ivy

et al. 2009

Journal of Biopharmaceutical Statistics

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The traditional and accelerated titration (AT) designs are two frequently utilized Phase I clinical trial designs. Although each design has theoretical advantages and disadvantages, a summary of the practical application of these theories has not been reported. We report our center's experience in evaluating novel agents using both types of Phase I trial designs over a 13-year period. Results from nine Phase I clinical trials of multiple cytotoxic agents conducted at Wayne State University/Karmanos Cancer Institute in Detroit, MI, and published from 1995–2005 were analyzed for this report. Parameters analyzed included the number of patients, the number of dose levels, the total time to completion of the study, and adverse events. The mean number of patients treated on four Phase I trials using the traditional Phase I trial design was 34 compared to a mean of 23.8 patients treated on five Phase I trials using the AT schema. The mean number of dose levels in patients treated using the traditional Phase I trial design was 8.8 (range 7–11) compared to a mean of 10.6 (range 7–15) dose levels using the AT design. The mean length of study time (25–26 months) was similar in both trial designs. The theoretical advantages and disadvantages of both Phase I trial designs did not readily emerge in their actual application in clinical trials conducted at our institution.

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Section: Methodsmentioning

confidence: 99%

Theoretical and Practical Application of Traditional and Accelerated Titration Phase I Clinical Trial Designs: The Wayne State University Experience

Heath

LoRusso

Ivy

et al. 2009

Journal of Biopharmaceutical Statistics

Self Cite

View full text Add to dashboard Cite

show abstract

“…The first consists of the co-administration of a large amount of uracil, which saturates the DPD enzyme because uracil is its natural substrate; for instance, the formulation known as UFT uses a 4:1 ratio of uracil and the 5-FU prodrug tegafur. 38 The combination of UFT with leucovorin calcium was called Orzel ® . 40 2.…”

Section: Decreased Degradation Of 5-fumentioning

confidence: 99%