Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT02079220
Brief Summary:
This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety, and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line treatment of subjects with mCRC.
Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice between arm A and arm B will depend on the investigator's preference.
Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days.
* Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days.
* Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days.
Arm B (every 3 week schedule):
Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days.
* Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days.
* Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days.
Study:
NCT02079220
Study Brief:
Protocol Section:
NCT02079220