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ABT-700

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |AbbVie Inc.|Trials Updated: Nov 21, 2017

ABT-700 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2011

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

ABT-700 clinical trials

ABT-700 · 1 trial · 1 indication

Phase 1 1
NCT01472016Study of ABT-700 in Subjects With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED74 Analytics
PHASE1COMPLETED
Study of ABT-700 in Subjects With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
First cycle of treatment through 60 day follow-up visit

Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring

To Evaluate the pharmacokinetics of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
At each cycle of treatment through 60 days after last dose.

Pharmacokinetic profile of ABT-700 analyzed from blood samples

To determine the recommended Phase 2 dose for ABT-700
First cycle of treatment through 60 day follow-up visit

Secondary Endpoints

To evaluate the preliminary efficacy of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Screening through 60 day follow-up visit
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort AEXPERIMENTALABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700.
Cohort BEXPERIMENTALABT-700 plus docetaxel.
Cohort CEXPERIMENTALABT-700 plus FOLFIRI/cetuximab
Cohort DEXPERIMENTALABT-700 plus erlotinib

Interventions

NameTypeDescription
ABT-700DRUGABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.
docetaxelDRUGDocetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
FOLFIRIDRUG5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
cetuximabDRUGCetuximab will be administered by intravenous infusion weekly.
erlotinibDRUGErlotinib will be taken orally daily.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification. * Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard the...

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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about ABT-700

What is ABT-700 used for?

ABT-700 is an investigational small molecule being studied for the treatment of advanced solid tumors. It was evaluated in a Phase 1 clinical trial in adult patients with advanced solid tumors. It is not an approved therapy and remains in clinical development.

Who is developing ABT-700?

ABT-700 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 1 study of ABT-700 in advanced solid tumors.

What phase is ABT-700 in?

ABT-700 is in Phase 1 development. One Phase 1 trial, NCT01472016, has been completed, and no active trials are currently listed. ABT-700 is investigational and has not been approved for any indication.

What clinical trials is ABT-700 in?

ABT-700 has been studied in one clinical trial, NCT01472016, titled Study of ABT-700 in Subjects With Advanced Solid Tumors. The Phase 1 trial enrolled 74 adults with advanced solid tumors and is now completed.

Was the ABT-700 trial randomized or blinded?

No. The Phase 1 trial of ABT-700, NCT01472016, was not randomized and was not double blinded. It used a controlled design and enrolled 74 participants aged 18 years and older with advanced solid tumors.

Was ABT-700 studied in biomarker-selected patients?

Yes. The clinical development of ABT-700 in advanced solid tumors was biomarker selected, meaning trial enrollment was guided by a biomarker rather than an unselected patient population.