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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT01111604
Eligibility Criteria:
Inclusion Criteria:
* Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI \[capecitabine + irinotecan\], with or without bevacizumab)
* Age ≥ 18 years
* Life expectancy of ≥ 6 months
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
* Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication
* Provided signed informed consent
Exclusion Criteria:
* Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered \> 12 months prior to randomization)
* Has documented and/or symptomatic brain or leptomeningeal metastases
* Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
* On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment \> 3 months prior to randomization is eligible
* Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy
* Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for \> 3 years
* If female, is pregnant (confirmed by serum beta human chorionic gonadotropin \[βHCG\] test) or lactating
* Has received a prior autologous or allogeneic organ or tissue transplantation
* Has undergone major surgery within 28 days prior to randomization
* Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
* Has an elective or planned major surgery to be performed during the course of the trial
* Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01111604
Study Brief:
Protocol Section:
NCT01111604