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:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00685204
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed malignant mesothelioma for which they have received pemetrexed in combination with cisplatin as part of chemotherapeutic regimen.
* Prior cancer therapy with pemetrexed/cisplatin must have been completed at least 30 days prior to the first cycle of milataxel; prior radiotherapy (less than 25% of the bone marrow) must have been completed at least 30 days prior to study enrollment.
* Patients must have measurable disease by the Modified RECIST criteria
* Patients must have a life expectancy of at least 12 weeks and an ECOG performance status of 0, 1 or 2
* Patients must be 18 years of age.
* Patients must have adequate organ and system function.
* Patients must be able to comply with the protocol treatments and procedures.
* Patients with known brain metastases may be included in the study, providing they are clinically stable.
* Recovered from all acute toxicities caused by prior cancer therapies, except for alopecia.
Exclusion Criteria:
* Patients must not have received any other chemotherapeutic treatment for malignant mesothelioma other than pemetrexed and a platinum agent such as cisplatin.
* Patients with grade 2 or greater peripheral neuropathy.
* Prior cancer therapies not completed within 30 days prior to the first cycle of milataxel; radiotherapy completed less than 30 days prior to study enrollment; patients not recovered from radiation-related toxicities; patients receiving any concurrent anti-cancer therapy, including trastuzumab, bevacizumab or an investigational agent while on-study; patients with greater than 2 prior radiotherapy treatments.
* Patients with known sensitivity to alcohol.
* Patients with significant intercurrent illnesses.
* Patients with symptomatic CNS metastases.
* Patients who have had major surgery within the past 14 days.
* Patients who require or are likely to require any strong modifier of CYP450 activity to be taken prior to milataxel administration
* Patients who are receiving high dose steroids (more than a dexamethasone-equivalent dose of 4 mg per day).
* Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or major resection of the stomach or small bowel that could affect absorption of the study drug.
* Women who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00685204
Study Brief:
Protocol Section:
NCT00685204