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M200, Carboplatin, Paclitaxel

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 21, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

M200, Carboplatin, Paclitaxel · 1 trial · 1 indication

Phase 1 1
NCT00654758A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel in First-line, Advanced Non-Small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer
COMPLETED33 Analytics
PHASE1COMPLETED
A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel 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 and paclitaxel
Dose escalation phase of the trial

Secondary Endpoints

Pharmacokinetics of volociximab
Approximately 2.5 years
Efficacy of volociximab in combination with carboplatin/paclitaxel
Approximately 2.5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEscalating doses of volociximab at 10, 20, and 30 (or 15) mg/kg with carboplatin and paclitaxel.

Interventions

NameTypeDescription
M200 (Volociximab), Carboplatin, PaclitaxelDRUGVolociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease 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 three 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 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria 1. Males and females at least 18 years of age. 2. Stage IIIB or IV or recurrent NSCLC. 3. Measurable and/or evaluable disease according to RECIST. 4. No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease. Adjuvant therapy for early stage disease mus...

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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about M200, Carboplatin, Paclitaxel

What is M200 used for?

M200 is an investigational small molecule being studied for the treatment of non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer. It is in Phase 1 clinical development and has not been approved by the FDA.

Who makes M200?

M200 is being developed by AbbVie Inc. (ticker: ABBV). The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is M200 in?

M200 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for M200 have been completed.

What clinical trials is M200 in?

M200 has been studied in two completed Phase 1 trials: NCT00635193, which evaluated M200 in combination with liposomal doxorubicin in ovarian cancer and primary peritoneal cancer, and NCT00654758, which studied M200 with carboplatin and paclitaxel in non-small cell lung cancer.

Is M200 the same as volociximab?

Yes, M200 is also known as volociximab. Clinical trial NCT00635193 is titled 'Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)', confirming that M200 and volociximab refer to the same drug.