Recent Updates
Recently added Catalysts

ABT-263

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

ABT-263 · 4 trials · 7 indications

Phase 1 4
NCT01021358A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).Lymphoma
COMPLETED12 Analytics
NCT01053520Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female SubjectsHealthy Female Subjects
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).
Lymphoma
NCT0102135812
Unlock trial analytics
PHASE1COMPLETED
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
Healthy Female Subjects
NCT0105352012
Unlock 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 Tumor
NCT0088810841
Unlock trial analytics
PHASE1COMPLETED
Assess the Oral Bioavailability of New ABT-263 Formulations
Chronic Lymphocytic Leukemia
NCT0074302836
Unlock trial analytics

Study Endpoints

Primary Endpoints

To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263.
Weekly
Assess the oral bioavailability of Formulation B1 and Formulation B2 via pharmacokinetic measurements relative to Formulation A .
Each formulation assessed via 13 PK timepoints over 4 days
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
Secondary outcome measures include adverse event monitoring, vital signs, physical examinations, ECGs, and laboratory assessments including pharmacogenetics.
Assessed over the confinement period of 17 days of study duration
Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of docetaxel.
Bimonthly
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A (ABT-263 and Ketoconozole)EXPERIMENTAL -
Sequence IEXPERIMENTAL -
Sequence IIEXPERIMENTAL -
Sequence IIIEXPERIMENTAL -
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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about ABT-263

What is ABT-263 used for?

ABT-263 is an investigational small molecule being studied for use in oncology, specifically in solid tumors, lymphoma, chronic lymphocytic leukemia, and healthy female subjects. It is being developed by Abbott Laboratories and is currently in Phase 1 clinical development.

What does ABT-263 target?

ABT-263 is a small molecule being developed by Abbott Laboratories for oncology indications. Its molecular target has not been disclosed in available clinical trial information, so its specific mechanism of action is not detailed here.

Who makes ABT-263?

ABT-263 is being developed by Abbott Laboratories, a company traded under the ticker symbol ABT. The drug is currently in Phase 1 clinical development for oncology indications including solid tumors, lymphoma, and chronic lymphocytic leukemia.

What phase is ABT-263 in?

ABT-263 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, but the drug remains under investigation for oncology indications.

What clinical trials is ABT-263 in?

ABT-263 has been studied in several Phase 1 clinical trials, including NCT00743028, NCT00888108, NCT01021358, and NCT01053520. These trials assessed oral bioavailability, safety, and drug interactions in patients with cancer and healthy subjects.

Is ABT-263 the same as Navitoclax?

ABT-263 is also known as Navitoclax. Clinical trial NCT01021358 refers to ABT-263 as Navitoclax, confirming that the two names refer to the same investigational drug being developed by Abbott Laboratories.