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 @ 11:55 AM
Ignite Modification Date:
2025-12-24 @ 11:55 AM
NCT ID:
NCT01004861
Eligibility Criteria:
Inclusion Criteria:
* Age 18 and older
* Solid tumors refractory to standard therapy
* For the Extension cohorts, patients must have measurable disease by RECIST criteria and meet the following disease-specific criteria:
* For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy.
* For pigmented villo-nodular synovitis (PVNS), patients must have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable tumor requesting mutilating surgery, as well as demonstrated progressive disease in the last 12 months.
* For gastrointestinal stromal tumors (GIST), patients must have failed previous therapy with imatinib and sunitinib. Patients with known PDGFR mutations are excluded, but mutation testing is not required for study entry.
* For anaplastic thyroid cancer (ATC), patients must have histologically or cytologically diagnosed advanced ATC.
* For metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain.
* Eastern Cooperative Oncology Group performance status 0 or 1
* Life expectancy \>= 3 months
* Adequate hepatic, renal, and bone marrow function
Exclusion Criteria:
* Specific anti-cancer therapy within 3 weeks of study start
* Uncontrolled intercurrent illness
* Refractory nausea or vomiting, or malabsorption
* Mean corrected QT interval (QTc) \>= 450 msec (for males) or QTc \>= 470 msec (for females)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01004861
Study Brief:
Protocol Section:
NCT01004861