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ABT-348

Phase 1

Acute Lymphoblastic Leukemia | Small molecule | Oncology |AbbVie Inc.|Trials Updated: Nov 20, 2017

ABT-348 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Apr 2010

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment154

FDA Designations

No designations recorded

ABT-348 clinical trials

ABT-348 · 2 trials · 6 indications

Phase 1 2
NCT01110473ABT-348 as Monotherapy and in Combination With Azacitidine to Treat Advanced Hematologic MalignanciesAcute Lymphoblastic Leukemia
COMPLETED52 Analytics
NCT01110486ABT-348 as Monotherapy or Combination With Carboplatin or Docetaxel to Treat Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED102 Analytics
PHASE1COMPLETED
ABT-348 as Monotherapy and in Combination With Azacitidine to Treat Advanced Hematologic Malignancies
Acute Lymphoblastic Leukemia
NCT0111047352
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PHASE1COMPLETED
ABT-348 as Monotherapy or Combination With Carboplatin or Docetaxel to Treat Advanced Solid Tumors
Advanced Solid Tumors
NCT01110486102
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Study Endpoints

Primary Endpoints

Determine the safety profile (adverse events by toxicity grade and relationship to study drug, serious adverse events, adverse events leading to discontinuation and relevant clinical laboratory abnormalities) of ABT-348 as monotherapy or in combination
At each treatment visit
Study the pharmacokinetic interaction (plasma concentrations and pharmacokinetic parameter values) of ABT-348 as monotherapy and in combination
At study visits
Study the pharmacokinetic of ABT-348
At study visits
Dose limiting toxicity determination
At each treatment visit until dose-limiting toxicities observed

Secondary Endpoints

Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) of ABT-348 when administered as a monotherapy and in combination in subjects with advanced hematologic malignancies
At each treatment visit
Evaluate safety at the recommended Phase 2 dose (RPTD) and schedule of ABT-348 as monotherapy, when in combination with carboplatin or in combination with docetaxel.
At RPTD treatment visit
Evaluate preliminary efficacy data regarding objective response rate (ORR), time to progression (TTP), duration of overall response, and ECOG performance status of ABT-348 as monotherapy, when in combination with carboplatin or docetaxel.
At each treatment visit
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monotherapy, once dailyEXPERIMENTAL -
Monotherapy, twice dailyEXPERIMENTAL -
Combination with AzacitidineEXPERIMENTAL -
IV monotherapy, once dailyEXPERIMENTAL -
Combination with carboplatinEXPERIMENTAL -
Combination with docetaxelEXPERIMENTAL -

Interventions

NameTypeDescription
ABT-348DRUGAn oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
ABT-348 and azacitidineDRUGAn oral dose of ABT-348 on Day 1, Day 8, and Day 15 of each 28 day cycle. An IV or injection of azacitidine on Days 1-7 of each 28 day cycle.
ABT-348 and carboplatinDRUGAn oral dose of ABT-348 will begin in Cycle 2on Day 1 and Day 8; and an IV dose of carboplatin (AUC 5.0) on Day 1 of each 21-day cycle.
ABT-348 and docetaxelDRUGABT-348 dosing will begin in Cycle 2. An oral dose of ABT-348 on Day 1 and Day 8; and an IV dose of docetaxel (75 mg/m2) on Day 1 of each 21-day cycle.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Histological or cytological confirmation of one of the following (Arms A, B and D): * Relapsed or refractory acute myelogenous leukemia (AML), untreated AML in subjects who are \> 60 years of age and do not have favorable cytogenetics (i.e., lack t(8,21) or inv(16)/t(16,1...

Countries:United States
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Frequently asked questions about ABT-348

What is ABT-348 used for?

ABT-348 is an investigational small molecule being studied for the treatment of acute lymphoblastic leukemia and advanced solid tumors. It is in Phase 1 clinical development for these oncology indications.

Who makes ABT-348?

ABT-348 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.

What phase is ABT-348 in?

ABT-348 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for acute lymphoblastic leukemia and advanced solid tumors.

What clinical trials is ABT-348 in?

ABT-348 has been studied in two completed Phase 1 clinical trials. NCT01110473 evaluated ABT-348 as monotherapy and in combination with azacitidine for advanced hematologic malignancies, including acute lymphoblastic leukemia. NCT01110486 evaluated ABT-348 as monotherapy or in combination with carboplatin or docetaxel for advanced solid tumors.

Is ABT-348 the same as any other drug?

ABT-348 is the primary name for this investigational compound. No alternative names have been established for this drug in clinical development.

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