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Rilotumumab

Phase 1

Part 1- Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Feb 29, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Rilotumumab · 1 trial · 3 indications

Phase 1 1
NCT01791374Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJPart 1- Advanced Solid Tumors
COMPLETED21 Analytics
PHASE1COMPLETED
Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ
Part 1- Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part1: Dose-limiting toxicities (DLT) for each dose level of rilotumumab tested
28 days

DLTs are defined as grade 3 or higher adverse events that are related to rilotumumab during the first cycle of therapy. This does not include specific toxicities (eg nausea and vomiting) that are common in cancer patients unless specific criteria are met.

Part 2: Dose-limiting toxicities (DLT) for each dose level of rilotumumab in combination with cisplatin and capecitabine (CX) chemotherapy tested
21 days

DLTs are defined as grade 3 or higher adverse events that are related to rilotumumab or the combination of rilotumumab and CX during the first cycle of therapy. This does not include specific toxicities (eg nausea and vomiting) that are common in cancer patients unless specific criteria are met.

Secondary Endpoints

Part 1: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies.
4 months average
Part 1: Pharmacokinetics parameters of rilotumumab monotherapy as measured by: Maximum concentration, time to achieve maximum concentration, observed minimum concentration, area under the concentration-time curve, terminal elimination half-life.
4 months average
Part 1: Evaluate efficacy based on the treatment effects of rilotumumab monotherapy as measured by the following: Objective Response Rate, duration of response, progression-free survival.
4 months average
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rilotumumab MonotherapyEXPERIMENTALCohort 1A: Rilotumumab 10 mg/kg IV Q2W Cohort 1B: Rilotumumab 20 mg/kg IV Q2W Cohort 1C (if needed): Rilotumumab 15 mg/kg IV Q2W
Rilotumumab plus CXEXPERIMENTALCohort 2A: Rilotumumab 15 mg/kg IV Day 1 Q3W Cisplatin 80 mg/m2 IV (max of 6 cycles) Day 1 Q3W Capecitabine 1000 mg/m2 PO BID, Days 2-14 Q3W Cohort 2B (if needed): Rilotumumab 10 mg/kg IV Day 1 Q3W Cisplatin 80 mg/m2 IV (max of 6 cycles) Day 1 Q3W Capecitabine 1000 mg/m2 PO BID, Days 2-14 Q3W

Interventions

NameTypeDescription
RilotumumabDRUGRilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells.
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Eligibility Criteria

Age Range20 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: * Japanese subjects with pathologically confirmed unresectable locally advanced or metastatic carcinoma which is refractory to standard therapies or for which there is no standard therapy (Part 1 only) * Japanese subjects with pathologically confirmed MET-positive (fulfillin...

Countries:Japan
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Part 1- Advanced Solid Tumors")

Frequently asked questions about Rilotumumab

What is Rilotumumab used for?

Rilotumumab is an investigational oncology drug being studied for use in advanced solid tumors. It was evaluated in a Phase 1 clinical trial that included a part for advanced solid tumors and a part for advanced or metastatic gastric or gastroesophageal junction cancer. The drug is still in clinical development.

Who makes Rilotumumab?

Rilotumumab is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen sponsored the clinical trial of Rilotumumab in Japanese subjects with advanced solid tumors or advanced or metastatic gastric or gastroesophageal junction cancer.

What phase is Rilotumumab in?

Rilotumumab is in Phase 1 clinical development. A Phase 1/1b study of Rilotumumab in Japanese subjects with advanced solid tumors or advanced or metastatic gastric or gastroesophageal junction cancer has been completed. The drug is investigational and has not been approved for any use.

What clinical trials is Rilotumumab in?

Rilotumumab has been studied in one completed clinical trial, identified as NCT01791374. This was a Phase 1/1b study in Japanese subjects with advanced solid tumors or advanced or metastatic gastric or gastroesophageal junction cancer. The trial enrolled 21 participants and was conducted in Japan.

Is Rilotumumab a small molecule?

Yes, Rilotumumab is a small molecule drug. It is being developed as an oncology treatment and was studied in a controlled Phase 1 clinical trial. The trial was not randomized or double-blind, and it enrolled adult participants aged 20 years and older.