Spots Global Cancer Trial Database for 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
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Trial Identification
Brief 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
Official Title: A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer
Study ID: NCT06107413
Study Description
Brief Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer. ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab (FFB) in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care \[SOC\]) \[dose optimization\] on its own. Approximately 206 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide. In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with FFB at low or high doses determined in the safety lead in on two different dosing schedules. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. The study will run for a duration of approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, PA /ID# 259424, Springdale, Arkansas, United States
City of Hope National Medical Center /ID# 257576, Duarte, California, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 260563, Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601, Fort Wayne, Indiana, United States
Community Health Network, Inc. /ID# 257078, Indianapolis, Indiana, United States
Duke Cancer Center /ID# 257236, Durham, North Carolina, United States
Medical University of South Carolina /ID# 258486, Charleston, South Carolina, United States
Millennium Research and Clinical Development /ID# 257780, Houston, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 257261, Fairfax, Virginia, United States
Tel Aviv Sourasky Medical Center /ID# 257090, Tel Aviv, Tel-Aviv, Israel
Hadassah /ID# 257088, Jerusalem, Yerushalayim, Israel
Aichi Cancer Center Hospital /ID# 257286, Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East /ID# 257282, Kashiwa-shi, Chiba, Japan
Kyoto University Hospital /ID# 257287, Kyoto-shi, Kyoto, Japan
National Cancer Center Hospital /ID# 257284, Chuo-ku, Tokyo, Japan
Yonsei University Health System Severance Hospital /ID# 257492, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 257493, Seoul, , Korea, Republic of
National Taiwan University Hospital /ID# 257639, Taipei City, , Taiwan
Taipei Veterans General Hosp /ID# 257636, Taipei, , Taiwan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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