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Assess whether the combination of ABT-888 with FOLFIRI has activity in subjects with gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veliparib and FOLFIRI | Experimental | Veliparib in combination with FOLFIRI regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib | Drug | Subjects will be given Veliparib twice daily on Days 1-5 and 15-19 every 28 days orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the MTD and establish the recommended phase 2 dose of Veliparib in combination with two different FOLFIRI regimens that include a reduced regimen (150 mg/m2 irinotecan) and the standard regimen (180 mg/m2) in subjects with advanced solid tumors | Screening to follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability, pharmacokinetic profile of the combination at each of the FOLFIRI regimens. | Screening to follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie Shepherd, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 24987 | Scottsdale | Arizona | 85258 | United States | ||
| Site Reference ID/Investigator# 24985 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27239108 | Background | Jou E, Rajdev L. Current and emerging therapies in unresectable and recurrent gastric cancer. World J Gastroenterol. 2016 May 28;22(20):4812-23. doi: 10.3748/wjg.v22.i20.4812. | |
| 29527010 | Background | Berlin J, Ramanathan RK, Strickler JH, Subramaniam DS, Marshall J, Kang YK, Hetman R, Dudley MW, Zeng J, Nickner C, Xiong H, Komarnitsky P, Shepherd SP, Hurwitz H, Lenz HJ. A phase 1 dose-escalation study of veliparib with bimonthly FOLFIRI in patients with advanced solid tumours. Br J Cancer. 2018 Apr;118(7):938-946. doi: 10.1038/s41416-018-0003-3. Epub 2018 Mar 12. |
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| Los Angeles |
| California |
| 90033 |
| United States |
| Site Reference ID/Investigator# 26742 | Los Angeles | California | 90033 | United States |
| Site Reference ID/Investigator# 24986 | Washington D.C. | District of Columbia | 20007 | United States |
| Site Reference ID/Investigator# 24922 | Durham | North Carolina | 27710 | United States |
| Site Reference ID/Investigator# 24983 | Nashville | Tennessee | 37232-6868 | United States |
| Site Reference ID/Investigator# 75713 | Seoul | 138-736 | South Korea |
| Site Reference ID/Investigator# 75714 | Seoul | South Korea |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C521013 | veliparib |
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