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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT01105533
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
* At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors \[RECIST\].
* Adequate bone marrow, liver function and renal function as defined by protocol.
* Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.
During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.
Exclusion Criteria:
* Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry
* Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
* Patients with carcinomatous meningitis or un-treated brain metastases.
* Any acute cardiovascular incident within the past 12 months.
* Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol
* Patients with no evidence of the following for 5 years: malignancy or metastatic disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or T1C prostate cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01105533
Study Brief:
Protocol Section:
NCT01105533