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ABI-007 and Carboplatin

Phase 2

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 12, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

ABI-007 and Carboplatin · 1 trial · 1 indication

Phase 2 1
NCT00274443An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With CarboplatinNon-Small Cell Lung Cancer (NSCLC)
COMPLETED250 Analytics
PHASE2COMPLETED
An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With Carboplatin
Non-Small Cell Lung Cancer (NSCLC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety Outcomes: incidence of treatment emergent adverse events.
Treatment duration
Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response
Treatment duration
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABI-007 and CarboplatinEXPERIMENTALABI-007 and Carboplatin in patients with Advanced Non-Small Cell Lung Cancer.

Interventions

NameTypeDescription
ABI-007 (Abraxane) and CarboplatinDRUGABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks
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Eligibility Criteria

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

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC Stage IIIB with pleural effusion or evidence of inoperable local recurrence or metastasis (Stage IV). * Male or non-pregnant and non-lactating female, and ≥ 18 years of age. ( )If a female patient is of child-bearing potential, a...

Countries:Russia
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Frequently asked questions about ABI-007 and Carboplatin

What is ABI-007 used for?

ABI-007 is an investigational small molecule being studied for the treatment of several cancers, including breast cancer, non-small cell lung cancer, melanoma, and colorectal neoplasms. Clinical trials have evaluated it in patients with metastatic breast cancer, advanced non-small cell lung cancer, and metastatic melanoma.

Who makes ABI-007?

ABI-007 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research on this investigational oncology drug.

What phase is ABI-007 in?

ABI-007 is in Phase 3 clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is ABI-007 in?

ABI-007 has been studied in several completed clinical trials. NCT00046514 evaluated it in taxol-resistant patients with metastatic breast cancer, NCT00046527 compared it with Taxol in metastatic breast cancer, NCT00073723 tested it in chemotherapy-naive patients with advanced non-small cell lung cancer, and NCT00093119 studied it in previously treated patients with metastatic melanoma.

How does ABI-007 work?

ABI-007 is a small molecule therapeutic. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its anti-cancer activity across multiple tumor types.

Is ABI-007 the same as Abraxane?

ABI-007 is also known as Abraxane, a formulation of paclitaxel bound to albumin. Clinical trials have used the name ABI-007 to refer to this drug, which has been studied in breast cancer, non-small cell lung cancer, and melanoma.