Clinical TrialID 8228
Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab
NCT06107413
Unresectable Metastatic Colorectal Cancer
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8228
- Evidence Id
- 8228
- Core Evidence Id
- 8228
- Source Clinical Trial Id
- 8226
- Herb2 Clinical Trial Id
- HBCT008226
- Nct Id
- NCT06107413
- Title
- Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Unresectable Metastatic Colorectal Cancer
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: ABBV-400|DRUG: Bevacizumab|DRUG: Folinic Acid|DRUG: Fluorouracil|DRUG: Irinotecan
- Intervention Allocation
- Randomized
- Intervention Model
- Sequential
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 206
- Outcome Measure
- Percentage of Participants with Objective Response, OR is defined as complete response (CR) and partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as assessed by the investigator., Up to 24 Weeks|Progression Free Survival (PFS), PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier., Up to 11 Months
- Sponsor Collaborator
- AbbVie
- Funded By
- INDUSTRY
- Location
- Highlands Oncology Group, PA /ID# 259424, Springdale, Arkansas, 72762, United States|City of Hope National Medical Center /ID# 257576, Duarte, California, 91010, United States|Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 260563, Chicago, Illinois, 60611-2927, United States|Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601, Fort Wayne, Indiana, 46804, United States|Community Health Network, Inc. /ID# 257078, Indianapolis, Indiana, 46250-2042, United States|Duke Cancer Center /ID# 257236, Durham, North Carolina, 27710-3000, United States|Medical University of South Carolina /ID# 258486, Charleston, South Carolina, 29425, United States|MD Anderson Cancer Center /ID# 258713, Houston, Texas, 77030, United States|Millennium Research and Clinical Development /ID# 257780, Houston, Texas, 77090-3063, United States|Virginia Cancer Specialists - Fairfax /ID# 257261, Fairfax, Virginia, 22031, United States|Tel Aviv Sourasky Medical Center /ID# 257090, Tel Aviv, Tel-Aviv, 6423906, Israel|Hadassah /ID# 257088, Jerusalem, Yerushalayim, 91120, Israel|Aichi Cancer Center Hospital /ID# 257286, Nagoya-shi, Aichi, 464-8681, Japan|National Cancer Center Hospital East /ID# 257282, Kashiwa-shi, Chiba, 277-8577, Japan|Kyoto University Hospital /ID# 257287, Kyoto-shi, Kyoto, 606-8507, Japan|National Cancer Center Hospital /ID# 257284, Chuo-ku, Tokyo, 104-0045, Japan|Seoul National University Hospital /ID# 257493, Seoul, Seoul Teugbyeolsi, 03080, Korea, Republic of|Yonsei University Health System Severance Hospital /ID# 257492, Seoul, 03722, Korea, Republic of|National Taiwan University Hospital /ID# 257639, Taipei City, Taipei, 100, Taiwan|Taipei Veterans General Hosp /ID# 257636, Taipei, 11217, Taiwan
- Other Id
- M24-311|2023-505110-14-00
- Start Date
- 2023-11-12
- Primary Completion Date
- 2026-10-01
- Completion Date
- 2026-10-01
- First Posted
- 2023-10-30
- Results First Posted
- Last Update Posted
- 2024-10-03
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT06107413
- Title Cn
- Title En
- Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab
- Bilingual Status
- semi_complete