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M200

Phase 1

Ovarian Cancer, Primary Peritoneal Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Jan 18, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

M200 · 1 trial · 1 indication

Phase 1 1
NCT00635193Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)Ovarian Cancer, Primary Peritoneal Cancer
COMPLETED138 Analytics
PHASE1COMPLETED
Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
Ovarian Cancer, Primary Peritoneal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
50-57 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1OTHERThree subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk
Cohort 2OTHERliposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk
Group AOTHERliposomal doxorubicin, 40 mg/m2 q4wk
Group BOTHERliposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule)
Group COTHERliposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule)

Interventions

NameTypeDescription
M200 (Volociximab)DRUG7.5 mg/kg, IV infusion every week until disease progression
Liposomal DoxorubicinDRUG40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Females aged \>= 18 years old at the time of informed consent. * Advanced (Stage III or IV) histologically documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies). * Recurrent or persistent disease. * Received no more than 2 ...

Countries:United StatesAustraliaBelgiumItalyPolandRussiaSpainSwedenSwitzerland
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Frequently asked questions about M200

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.