Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT00751205
Eligibility Criteria:
Inclusion Criteria:
* 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 to 1
* No clinical residual neuropathy (CTCAE Grade 0 at baseline)
* Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia)
* 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%)
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00751205
Study Brief:
Protocol Section:
NCT00751205