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ABT-263

Phase 2

Chronic Lymphocytic Leukemia | Small molecule | Oncology |Abbott Laboratories|Trials Updated: May 22, 2012

ABT-263 development status

Highest phase Phase 2 (NCT00918450)
Phase scored for ABTPhase 1
Registered trials 17 across 5 sponsors since Dec 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment89

FDA Designations

No designations recorded

ABT-263 clinical trials

ABT-263 · 3 trials · 6 indications

Phase 1 3
NCT01021358A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).Lymphoma
COMPLETED12 Analytics
NCT00888108Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With CancerSolid Tumor
COMPLETED41 Analytics
NCT00743028Assess the Oral Bioavailability of New ABT-263 FormulationsChronic Lymphocytic Leukemia
COMPLETED36 Analytics
PHASE1COMPLETED
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).
LymphomaUnlock trial analytics
PHASE1COMPLETED
Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With Cancer
Solid TumorUnlock trial analytics
PHASE1COMPLETED
Assess the Oral Bioavailability of New ABT-263 Formulations
Chronic Lymphocytic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263.
Weekly
Assess the safety profile of navitoclax (ABT-263) when administered in combination with a standard and weekly regimen of docetaxel.
Weekly
Study the pharmacokinetic interaction of navitoclax (ABT-263) and docetaxel
Weekly
Determine the maximum tolerated dose (MTD) of navitoclax (ABT-263) with a standard regimen of docetaxel
Weekly
Determine the MTD of both navitoclax and docetaxel with a weekly schedule.
Weekly
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies.
Two Period crossover design.
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies and assess new ABT-263 formulations after once daily dosing (QD) and twice daily dosing (BID).
Three Period crossover design.

Secondary Endpoints

To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients.
Daily
Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of docetaxel.
Bimonthly
Evaluate preliminary data regarding progression free survival
Bimonthly
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A (ABT-263 and Ketoconozole)EXPERIMENTAL -
docetaxel +ABT-263EXPERIMENTAL -
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -
6EXPERIMENTAL -

Interventions

NameTypeDescription
ABT-263DRUGSubjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
KetoconazoleDRUGSubjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
DocetaxelDRUG75 mg/m2 will be given by intravenous infusion on day 1 of each 21 -day cycle. 30 mg/m2 will be given by intravenous infusion on day 1, 8, 15 of each 28 -day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 years of age or older. * Has a non-hematologic malignancy (radiographic, histologic, or cytologic confirmation), or hematologic malignancy (histologic or cytologic confirmation) that is either: relapsed or refractory to standard therapy, failed at least one prior therapy or...

Countries:United StatesNetherlandsUnited Kingdom
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Frequently asked questions about ABT-263

What is ABT-263?

ABT-263 is an investigational small molecule developed by Abbott Laboratories for oncology. It has been studied in chronic lymphocytic leukemia, lymphoma, and solid tumors. It is a Phase 1 agent and has not been approved by the FDA. Trials of ABT-263 have been completed, including studies in the United States, Netherlands, and United Kingdom.

What is ABT-263 used for?

ABT-263 has been studied for the treatment of chronic lymphocytic leukemia, lymphoma, and solid tumors. It is an investigational therapy and is not approved for any indication. Clinical trials of ABT-263 enrolled adults aged 18 years and older, including patients with leukemia, lymphoma, and solid tumor diagnoses.

Who makes ABT-263?

ABT-263 is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott conducted Phase 1 clinical trials of ABT-263 in chronic lymphocytic leukemia, lymphoma, and solid tumors. The program includes completed studies evaluating drug metabolism, combination therapy, and oral bioavailability.

What phase is ABT-263 in?

ABT-263 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. The Phase 1 trials of ABT-263 have been completed, including studies assessing ketoconazole effects on metabolism, combination with docetaxel, and oral bioavailability of new formulations.

What clinical trials is ABT-263 in?

ABT-263 has been evaluated in completed Phase 1 trials including NCT01021358, which assessed ketoconazole effects on ABT-263 metabolism in lymphoma, chronic lymphocytic leukemia, and solid tumors; NCT00888108, which studied ABT-263 with docetaxel in solid tumors; and NCT00743028, which assessed oral bioavailability of new ABT-263 formulations.

Is ABT-263 the same as navitoclax?

Yes, ABT-263 is also known as navitoclax. Both names refer to the same investigational small molecule developed by Abbott Laboratories. Navitoclax has been studied in Phase 1 trials for chronic lymphocytic leukemia, lymphoma, and solid tumors, including NCT01021358, which used the ABT-263 name in its title.