EUCTR2008-000879-26-IT
Active, not recruiting
Not Applicable
?Double-blind, randomized phase II study to Evaluate the safety and efficacy of Acetyl-l-carnitine in the prevention of Sagopilone-induced peripheral Neuropathy? - REASO
DrugsNICETILE*30CPR 500MG
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BAYER
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Histologically or cytologically proven
- •a)Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or clear cell tumors) or
- •b)Adenocarcinoma of the prostate
- •Specific for HRPC:
- •2\)At least 1 unidimensionally measurable lesion (suitable for RECIST evaluation) or for patients without measurable disease PSA value ≥ 5 ng/mL
- •3\)Progression of disease despite adequate androgen\-inhibiting hormone therapy, demonstrated by:
- •\- rising PSA on at least 2 consecutive measurements taken at least 7 days apart. The last measurement must be 50% greater than the lowest PSA value achieved under the last previous treatment.
- •\- PSA at least 5 ng/ml
- •4\)PSA value at screening (4 to 6 weeks after cessation of antiandrogen treatment) must continue to be elevated
- •5\)Serum testosterone \< 50 ng/mL (ongoing treatment with luteinizing hormone\-releasing hormone (LHRH) analogues or orchiectomy)
Exclusion Criteria
- •1\)Candidacy for curative resection
- •2\)Symptomatic brain metastases requiring whole\-brain irradiation
- •3\)Congenital bleeding diathesis, acquired coagulopathy or patients receiving full dose of anticoagulants for the treatment of thromboembolism
- •4\)Any concomitant malignancy: the following exceptions are allowed:
- •a)Non\-melanoma skin cancer
- •b)Carcinoma in situ of the cervix
- •c)Malignancy with definitive treatment ≥ 5 years ago without relapse
- •5\)History of organ allograft
- •6\)Diabetes mellitus (even if controlled only by special diet)
- •7\)History of chronic hepatitis B or C or known HIV infection
Outcomes
Primary Outcomes
Not specified
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