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An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with locally advanced rectal cancer (LARC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| veliparib and capecitabine and radiation | Experimental | Veliparib on days 1-7, capecitabine and radiation on days 1-5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| veliparib | Drug | see arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD) | From first study drug dose and at each weekly treatment visit until dose-limiting toxicities (DLT) observed or completion of dosing period (anticipated to be approximately 5 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety (number of participants with adverse events and types of adverse events observed) | From screening and ongoing at each weekly treatment visit through dosing period (anticipated to be approximately 5 weeks), prior to surgery and at the final visit. | |
| Assess the tolerability (number of participants with adverse events and types of adverse events observed) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Komarnitsky, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 99095 | Scottsdale | Arizona | 85258 | United States | ||
| Site Reference ID/Investigator# 68044 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28497757 | Result | Czito BG, Deming DA, Jameson GS, Mulcahy MF, Vaghefi H, Dudley MW, Holen KD, DeLuca A, Mittapalli RK, Munasinghe W, He L, Zalcberg JR, Ngan SY, Komarnitsky P, Michael M. Safety and tolerability of veliparib combined with capecitabine plus radiotherapy in patients with locally advanced rectal cancer: a phase 1b study. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):418-426. doi: 10.1016/S2468-1253(17)30012-2. Epub 2017 Mar 27. |
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| capecitabine | Drug | see arm description |
|
|
| radiation | Radiation | see arm description |
|
| From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks). |
| Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib | Multiple measurements over time points (0, .5, 1, 2, 3, 4, 6 hours post dose) Day 1, Day 2 and at the pre-dose time point on Day 5 and week 2 visit. |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Site Reference ID/Investigator# 112395 | Goshen | Indiana | 46526 | United States |
| Site Reference ID/Investigator# 68045 | Durham | North Carolina | 27710 | United States |
| Site Reference ID/Investigator# 68043 | Madison | Wisconsin | 53792 | United States |
| Site Reference ID/Investigator# 67882 | East Melbourne | 3002 | Australia |
| ID | Term |
|---|---|
| C521013 | veliparib |
| D000069287 | Capecitabine |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D055585 | Physical Phenomena |
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