(REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy.

Bayer0 个研究点目标入组 150 人开始时间: 2012年4月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Males or females aged >/= 18 years
•- Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or
•clear cell tumors) or Adenocarcinoma of the prostate
•- At least 1 unidimensional measurable lesion (suitable for RECIST evaluation) or for
•patients without measurable disease, CA 125 levels >/= 2 times the upper limit of
•normal (ULN) within 3 months and confirmed within 2 weeks prior to first infusion
•(ovarian cancer) or PSA value >/= 5 ng/mL (HRPC).
•- Progression of disease (HRPC) despite adequate androgen-inhibiting hormone therapy.
•- Progression of disease (Ovarian Cancer) or symptomatic relapse after previous therapy
•(elevated CA125 levels alone are insufficient for inclusion) WHO performance status 0
•- No clinical residual neuropathy (CTCAE Grade 0 at baseline)
•- Adequate recovery from previous surgery, radiation, and chemotherapy (excluding
•- Adequate function of major organs and systems.
•- Survival expectation =3 months
•- Histologically or cytologically proven:
•1. Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucionous
•cell tumors or clear cell tumors that have a clear cell component of >33%)

•- Symptomatic brain metastases requiring whole- brain irradiation
•- Any concomitant malignancy: the following exceptions are allowed: Non-melanoma skin
•cancer, Carcinoma in situ of the cervix, Malignancy with definitive treatment >/= 5
•years ago without relapse.
•- Diabetes mellitus (even if controlled only by special diet)
•- History of chronic hepatitis B or C, or known HIV infection
•- Seizure disorder requiring medication (such as steroids or anti-epileptics)
•- Inability to swallow oral medications
•- Prior treatment with epothilones
•- Concomitant use of neurotoxic drugs
•- Concomitant use of compounds that have potentially positive effects towards symptoms
•of neuropathy

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