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This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate safety of ABT-263 monotherapy (Arm C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (ABT-263 and erlotinib) | Experimental |
| |
| Arm B (ABT-263 and irinotecan) | Experimental |
| |
| Arm C (ABT-263 monotherapy) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-263 | Drug | ABT-263 is taken orally. Note - The dose and schedule is variable based on Arm and subject to change based on the toxicities observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arm A | • assess the safety profile of ABT-263 in combination with erlotinib; • study the pharmacokinetic interaction between ABT-263 and erlotinib; • determine the maximum tolerated dose (MTD) of ABT-263 when administered with erlotinib | Weekly |
| Arm B | • assess the safety profile of ABT-263 in combination with irinotecan; • study the pharmacokinetic interaction between ABT-263 and irinotecan; • determine the maximum tolerated dose (MTD) of ABT-263 when administered with irinotecan.s | Weekly |
| Arm C | • assess the safety profile of ABT-263 as a monotherapy | Weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Holen | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 37463 | Santa Monica | California | 90404 | United States | ||
| Site Reference ID/Investigator# 36342 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26420235 | Result | Tolcher AW, LoRusso P, Arzt J, Busman TA, Lian G, Rudersdorf NS, Vanderwal CA, Kirschbrown W, Holen KD, Rosen LS. Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Nov;76(5):1025-32. doi: 10.1007/s00280-015-2883-8. Epub 2015 Sep 29. |
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| erlotinib | Drug | 150 mg of erlotinib is taken orally once daily. |
|
| irinotecan (3-week schedule) | Drug | 180 mg/m2 over 90 minutes, irinotecan will be given by intravenous infusion on Day 1 of each 21 day cycle. Note - The dose and schedule is subject to change based on the toxicities observed. |
|
| irinotecan (weekly schedule) | Drug | 75 mg/m2 over 45 minutes, irinotecan will be given by intravenous infusion on Days 1 and 8 of each 21 day cycle. Note - The dose and schedule is subject to change based on the toxicities observed. |
|
| Detroit |
| Michigan |
| 48201 |
| United States |
| Site Reference ID/Investigator# 24046 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 44917 | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| C528561 | navitoclax |
| D000069347 | Erlotinib Hydrochloride |
| D000077146 | Irinotecan |
| D001071 | Appointments and Schedules |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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