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M200, Carboplatin, Paclitaxel, Bevacizumab

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Abbott Laboratories|Last Updated: Apr 27, 2012

Target and mechanism

ModalitySmall molecule

Also known as M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

M200, Carboplatin, Paclitaxel, Bevacizumab · 1 trial · 1 indication

Phase 1 1
NCT00666692A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer
COMPLETED7 Analytics
PHASE1COMPLETED
A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin, paclitaxel, and bevacizumab.
Dose Limiting Toxicities (DLT) will be assessed during the first treatment cycle for each cohort

Secondary Endpoints

1) Pharmacokinetics of volociximab 2) Efficacy of volociximab in combination with carboplatin/paclitaxel and bevacizumab.
Throughout study period
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEscalating doses of volociximab at 10, 20, and 30 mg/kg with carboplatin, paclitaxel, and bevacizumab

Interventions

NameTypeDescription
M200 (Volociximab), Carboplatin, Paclitaxel, BevacizumabDRUGVolociximab will be administered via IV infusion once every three week at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels on Day 8 of the first cycle. Volociximab will be given for up to 6 cycles (3 weeks/cycle). Subjects who have stable disease or better and subjects who have disease that is not progressing at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All four drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria * Males and females of at least 18 years of age. * Stage IIIB with pleural effusion or Stage IV non-squamous NSCLC. * Measurable and/or evaluable disease according to RECIST. * No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease. Adjuvant therapy ...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials