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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT00460603
Eligibility Criteria:
Inclusion Criteria:
* (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
* (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
* Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was \> 12 months prior to enrollment,
* Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.
Exclusion Criteria:
* Prior system therapy for advanced CRC (Ph 2 portion only)
* Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
* Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
* Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed \> 2 weeks of enrollment and be fully recovered from any procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00460603
Study Brief:
Protocol Section:
NCT00460603