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BIIB022 With Paclitaxel and Carboplatin

Phase 3

Hepatocellular Carcinoma | Small molecule | Oncology |Biogen Inc.|Trials Updated: Jan 9, 2017

BIIB022 With Paclitaxel and Carboplatin development status

Highest phase Phase 3 run by Achieve Life Sciences (NCT00251095)
Phase scored for BIIBPhase 1
Registered trials 15 across 13 sponsors since Nov 2005

BIIB022 With Paclitaxel and Carboplatin target and mechanism

ModalitySmall molecule

Also known as BIIB022, Taxol, Paraplatin, Taxane, Anti-IGF-1R, Cytotoxic, Mitotic Inhibitor, IGF-1R

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials3
Total Enrollment98

FDA Designations

No designations recorded

BIIB022 With Paclitaxel and Carboplatin clinical trials

BIIB022 With Paclitaxel and Carboplatin · 3 trials · 3 indications

Phase 1 3
NCT00970580A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung CancerNon-Small Cell Lung Cancer
COMPLETED18 Analytics
NCT00956436Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma
COMPLETED40 Analytics
NCT00555724Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid TumorsSolid Tumors
COMPLETED40 Analytics
PHASE1COMPLETED
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer
Non-Small Cell Lung CancerUnlock trial analytics
PHASE1COMPLETED
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
Hepatocellular CarcinomaUnlock trial analytics
PHASE1COMPLETED
Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin
6 months
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
6 months
To evaluate the safety and tolerability of BIIB022
ongoing

Secondary Endpoints

To evaluate the PK profile of BIIB022 and sorafenib in this study population
6 months
To assess the anti-tumor response in this study population
6 months
To evaluate pharmacokinetics
ongoing
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIIB022 in Combination with Paclitaxel and CarboplatinEXPERIMENTALBIIB022 in Combination with Paclitaxel and Carboplatin
Sorafenib MonotherapyEXPERIMENTALSorafenib Monotherapy
Sorafenib with BIIB022EXPERIMENTALSorafenib with BIIB022
BIIB022EXPERIMENTAL -

Interventions

NameTypeDescription
BIIB022 With Paclitaxel and CarboplatinDRUGEscalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin
BIIB022DRUGIV Q3W
SorafenibDRUGStandard dosing of Sorafenib
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Age \>/= 18 years old * Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer * ECOG Performance Status 0 or 1 Exclusion Criteria: * History of another primary cancer within 3 years * Any prior or concurrent investigational or standard therapy for treatment of NSCLC * Pri...

Countries:United StatesSingaporeTaiwanUnited Kingdom
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Frequently asked questions about BIIB022 With Paclitaxel and Carboplatin

What is BIIB022 used for?

BIIB022 is an investigational agent studied in oncology for hepatocellular carcinoma, non-small cell lung cancer, and solid tumors. It was evaluated in Phase 1 trials, including in combination with paclitaxel and carboplatin in non-small cell lung cancer and with sorafenib in hepatocellular carcinoma. It is not an approved therapy.

What does BIIB022 target?

BIIB022 is an anti-IGF-1R monoclonal antibody, meaning it targets insulin-like growth factor 1 receptor (IGF-1R). By binding this receptor, it is designed to interfere with IGF-1R mediated signaling in tumor cells. It was studied in relapsed or refractory solid tumors as well as in combination regimens.

Who is developing BIIB022?

BIIB022 was developed by Biogen Inc., which trades on Nasdaq under the ticker BIIB. The company sponsored the Phase 1 clinical program evaluating BIIB022 across solid tumors, non-small cell lung cancer, and hepatocellular carcinoma.

What phase is BIIB022 in?

BIIB022 is in Phase 1 development. All of its recorded clinical trials were Phase 1 studies, and those trials are completed. There are no active trials of BIIB022, and the agent is not approved for any indication.

What clinical trials is BIIB022 in?

BIIB022 was studied in three completed Phase 1 trials: NCT00970580 in non-small cell lung cancer with paclitaxel and carboplatin, NCT00956436 in hepatocellular carcinoma with sorafenib, and NCT00555724 in relapsed or refractory solid tumors. These trials enrolled patients in the United States and several other countries.