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M200, Carboplatin, Paclitaxel

Phase 1/2

Ovarian Cancer, Primary Peritoneal Cancer | Biologics | Oncology |AbbVie Inc.|Trials Updated: Nov 21, 2017

M200, Carboplatin, Paclitaxel target and mechanism

ModalityBiologics

Also known as M200 (Volociximab), M200

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment171

FDA Designations

No designations recorded

M200, Carboplatin, Paclitaxel clinical trials

M200, Carboplatin, Paclitaxel · 2 trials · 2 indications

Phase 1/2 1Phase 1 1
NCT00635193Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)Ovarian Cancer, Primary Peritoneal Cancer
COMPLETED138 Analytics
PHASE1/PHASE2COMPLETED
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
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

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

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.
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 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, Carboplatin, Paclitaxel

What is M200 (Volociximab) used for?

M200, also known as volociximab, has been studied in oncology for advanced non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer. It was evaluated in combination with carboplatin and paclitaxel in first-line NSCLC and with liposomal doxorubicin in ovarian and primary peritoneal cancers. It is an investigational monoclonal antibody and is not approved for any indication.

What does M200 (Volociximab) target?

M200 (volociximab) is a monoclonal antibody. No molecular target is specified in the available information, so its precise mechanism of action cannot be described here. It was developed as an oncology therapeutic and studied in combination with chemotherapy agents such as carboplatin, paclitaxel, and liposomal doxorubicin.

Who is developing M200 (Volociximab)?

M200 (volociximab) was developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. The company sponsored the clinical trials evaluating M200 in combination with carboplatin and paclitaxel for non-small cell lung cancer and with liposomal doxorubicin for ovarian and primary peritoneal cancers.

What phase is M200 (Volociximab) in?

M200 (volociximab) is in Phase 1 development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The clinical program includes completed Phase 1 trials in non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer.

What clinical trials is M200 (Volociximab) in?

M200 (volociximab) has been studied in two completed Phase 1 trials. NCT00654758 evaluated M200 with carboplatin and paclitaxel in first-line advanced non-small cell lung cancer and enrolled 33 patients. NCT00635193 evaluated M200 with liposomal doxorubicin in ovarian and primary peritoneal cancer and enrolled 138 patients across multiple countries.

Is M200 the same as Volociximab?

Yes, M200 is also known as volociximab. The names refer to the same monoclonal antibody developed by AbbVie Inc. for oncology indications including non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer. It has been investigated in Phase 1 clinical trials in combination with chemotherapy.