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AMG 386, paclitaxel and carboplatin

Phase 1

Carcinoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Oct 14, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

AMG 386, paclitaxel and carboplatin · 1 trial · 4 indications

Phase 1 1
NCT01253681Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian CancerCarcinoma
COMPLETED27 Analytics
PHASE1COMPLETED
Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer
Carcinoma
NCT0125368127
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Study Endpoints

Primary Endpoints

To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers.
18 weeks of combination therapy

Secondary Endpoints

To evaluate the pharmacokinetics (Cmax, AUC and Cmin) of AMG 386 in combination with carboplatin and paclitaxel
Week 1 until Week 7
To estimate the incidence of anti-AMG 386 antibody formation
Week 1 until maximum of 1 year following first dose
To evaluate the objective response rate (ORR) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMG 386, paclitaxel and carboplatinEXPERIMENTAL15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.

Interventions

NameTypeDescription
AMG 386, paclitaxel and carboplatinDRUG15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Female subjects more than 18 years of age with newly diagnosed high-risk FIGO Stage I (grade 3, or aneuploid grade 1 or 2) or Stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplat...

Countries:AustraliaBelgiumSpain
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Competitive Landscape -Cholangiocarcinoma 58 trials (matched to "Carcinoma")

Top 20 of 23 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN11PHASE3Rilvegostomig, Capecitabine, Gemcitabine/Cisplatin, S-1
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE3Zanidatamab, Cisplatin, Gemcitabine, Pembrolizumab, Durvalumab
Eli Lilly and CompanyLLY4PHASE2Ramucirumab, Merestinib, Cisplatin, Gemcitabine
Tango Therapeutics, Inc.TNGX4PHASE3Ivosidenib
Zymeworks Inc.ZYME1PHASE3Futibatinib, Ivosidenib, Zanidatamab, Trastuzumab, Neratinib
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Pfizer Inc.PFE2PHASE2tucatinib, trastuzumab, fulvestrant
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2/PHASE3HMPL-453
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
Replimune Group, Inc.REPL1PHASE2RP2, Bevacizumab, Atezolizumab, Durvalumab
Gilead Sciences, Inc.GILD1PHASE2Gemcitabine, Cisplatin, Zimberelimab, Quemliclustat
Incyte CorporationINCY1PHASE2Pemigatinib, Durvalumab
Tyra Bioscience, IncTYRA1PHASE1Phase 1 Part A- dose escalation TYRA-200 taken once daily by mouth in 28-day cycles, Phase 1 Part B- dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
Cogent Biosciences, Inc.COGT1PHASE1CGT4859
Molecular Partners AG Sponsored ADRMOLN1PHASE2MP0317, Gemcitabine, Cisplatine, Durvalumab, Cisplatin
Summit Therapeutics IncSMMT1PHASE2Ivonescimab, FOLFOX regimen
Context Therapeutics, Inc.CNTX1PHASE1CT-95
MacroGenics, Inc.MGNX1PHASE1MGC028
NextCure, Inc.NXTC1PHASE1LNCB74
Precision BioSciences, Inc.DTIL3PHASE1CEA-targeted CAR-T cells
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Frequently asked questions about AMG 386, paclitaxel and carboplatin

What is AMG 386 used for?

AMG 386 is an investigational oncology drug being studied for advanced renal cell carcinoma, advanced solid tumors, carcinoma, gastrointestinal cancer, fallopian tube cancer, and locally recurrent and metastatic breast cancer. It is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes AMG 386?

AMG 386 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is an investigational small molecule in Phase 2 clinical development for multiple oncology indications.

What phase is AMG 386 in?

AMG 386 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed, including a Phase 2 study in advanced renal cell carcinoma.

What clinical trials is AMG 386 in?

AMG 386 has been studied in several completed clinical trials, including NCT00467025, a Phase 2 study in advanced renal cell carcinoma; NCT01331941, a pharmacokinetic study in advanced solid tumors and renal impairment; NCT01666977, a Phase 1b/2 trial in non-small cell lung cancer; and NCT01992341, a drug-drug interaction study with paclitaxel.

Is AMG 386 the same as trebananib?

AMG 386 is also known as trebananib. It is an investigational oncology drug being developed by Amgen Inc. for multiple cancer types, including advanced renal cell carcinoma and advanced solid tumors.