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A1: AMG 386/kg+ Liposomal doxorubicin

Phase 1

Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Sep 29, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

A1: AMG 386/kg+ Liposomal doxorubicin · 1 trial · 9 indications

Phase 1 1
NCT00770536AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CRCancer
COMPLETED103 Analytics
PHASE1COMPLETED
AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicity in subjects treated with AMG 386 + pegylated liposomal doxorubicin (cohort A) and with AMG 386 + topotecan
first 4 weeks of treatment

Secondary Endpoints

To evaluate the treatment effect as measured by: objective response rate (ORR), duration of response (DOR), PFS, change in tumor burden, CA 125 Response and Progression by GCIG and CA-125 duration of response
Treatment and follow-up phase of study
To evaluate the incidence of adverse events and clinical laboratory abnormalities not defined as DLTs.
first 4 weeks of treatment
To determine the pharmacokinetics of pegylated liposomal doxorubicin (and its metabolite, doxorubicinol), topotecan and AMG 386 (Cmax, AUC, and Cmin for intensive assessment; Cmax and Cmin for sparse assessment).
Treatment and follow-up phase of study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTALIn part 1, six subjects will be assigned to each cohort A or B. This is a dose escalation/de escalation study with a 6 + 3 design based on the incidence of DLTs (dose limiting toxicities) during the first 4 weeks of combined therapy \[(cohort A: AMG 386 and pegylated liposomal doxorubicin) or (cohort B: AMG 386 and topotecan)\].
Part 2EXPERIMENTALThe decision on declaration of a safe and tolerable dose during part 1 will lead to part 2 (cohort A: liposomal doxorubicin + AMG 386 MTD (max tolerated dose) of part 1, cohort B: Topotecan + AMG 386 MTD (max tolerated dose) of part 1

Interventions

NameTypeDescription
A1: AMG 386 10 mg/kg + Liposomal doxorubicinDRUGLiposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW
A3: AMG 386 15mg/kg + Liposomal doxorubicinDRUGA3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W
B1: AMG 386 10 mg/kg + TopotecanDRUGB1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule
B3: AMG 386 15mg/kg + TopotecanDRUGAMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Histologically or cytologically documented recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer * Subjects must have received at least one platinum containing regimen * Radiographically documented progression per RECIST criteria with modification...

Countries:United StatesAustraliaBelgium
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Frequently asked questions about A1: AMG 386/kg+ Liposomal doxorubicin

What is AMG 386 used for?

AMG 386 is an investigational small molecule being studied for the treatment of cancer, specifically in combination with pegylated liposomal doxorubicin or topotecan in patients with advanced recurrent epithelial ovarian cancer, as well as other solid tumors and gynecological malignancies. It is being developed by Amgen Inc. and is currently in Phase 1 clinical development.

What does AMG 386 target?

AMG 386 is an investigational small molecule that targets the angiopoietin pathway. It is being studied in combination with either pegylated liposomal doxorubicin or topotecan for the treatment of advanced recurrent epithelial ovarian cancer and other solid tumors. The drug is in Phase 1 clinical development by Amgen Inc.

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 currently in Phase 1 clinical development for the treatment of cancer, including advanced recurrent epithelial ovarian cancer and other solid tumors.

What phase is AMG 386 in?

AMG 386 is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of cancer, including advanced recurrent epithelial ovarian cancer and other solid tumors. The drug has completed one Phase 1 trial and is not yet approved by regulatory authorities.

What clinical trials is AMG 386 in?

AMG 386 has been studied in one completed Phase 1 clinical trial with the identifier NCT00770536. This trial evaluated AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in female patients with advanced recurrent epithelial ovarian cancer, as well as other solid tumors and gynecological malignancies.

Is AMG 386 the same as trebananib?

AMG 386 is also known as trebananib. It is an investigational small molecule being developed by Amgen Inc. for the treatment of cancer, including advanced recurrent epithelial ovarian cancer and other solid tumors. The drug is currently in Phase 1 clinical development.