NCT01791374

Brief Summary

This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2012

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

January 4, 2013

Last Update Submit

February 26, 2016

Conditions

Part 1- Advanced Solid TumorsPart 2- Advanced or Metastatic Gastric CancerPart 2- Advanced or Metastatic GEJ

Keywords

Advanced Solid TumorsAdvanced or Metastatic Gastric CancerAdvanced or Metastatic GEJGastric Cancer

Outcome Measures

Primary Outcomes (2)

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

    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.

    28 days

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

    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.

    21 days

Secondary Outcomes (6)

  • 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

  • Part 2: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies not defined as DLTs.

    7 months average

  • Part 2: Pharmacokinetics parameters of rilotumumab in combination with cisplatin and capecitabine as measured by: Maximum concentration, observed minimum concentration, area under the concentration-time curve.

    7 months average

  • +1 more secondary outcomes

Study Arms (2)

Rilotumumab Monotherapy

EXPERIMENTAL

Cohort 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

Drug: Rilotumumab

Rilotumumab plus CX

EXPERIMENTAL

Cohort 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

Drug: Rilotumumab

Interventions

RilotumumabDRUG

Rilotumumab 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.

Also known as: AMG 102
Rilotumumab Monotherapy

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 (fulfilling the MET IHC criteria as defined by validated IVD \[in vitro diagnostic\]) unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1)
  • Availability of archival tumor tissue (Part 2 only)
  • Evaluable (measurable or non-measurable) disease by RECIST 1.1 criteria
  • Able to tolerate infusions and take oral medications (Part 2 only)

You may not qualify if:

  • Previous systemic therapy (including chemotherapy, biologic, immunotherapy, or investigational therapy) for locally advanced or metstatic gastric or GEJ adenocarcinoma (Part 2 only)
  • Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemotherapy to enrollment (Part 2 only)
  • Squamos cell history (Part 2 only)
  • Known HER2-overexpressing unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
  • Resectable disease or suitable for definitive chemoradiation
  • Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding (Part 2 only)
  • Known central nervous system metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Nagoya, Aichi-ken, 464-8681, Japan

Location

Research Site

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Research Site

Matsuyama, Ehime, 791-0280, Japan

Location

Research Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Research Site

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

Research Site

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Research Site

Suntou-gun, Shizuoka, 411-8777, Japan

Location

Related Publications (1)

  • Doi T, Yamaguchi K, Komatsu Y, Muro K, Nishina T, Nakajima TE, Tang R, Yang H, Zhang Y, Jung AS, Ang A, Yasui H. A Phase 1/1b tolerability study of rilotumumab alone or in combination with cisplatin and capecitabine in Japanese patients with gastric cancer. Jpn J Clin Oncol. 2017 Nov 1;47(11):1002-1009. doi: 10.1093/jjco/hyx114.

    PMID: 28973403DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

rilotumumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

February 15, 2013

Study Start

November 1, 2012

Primary Completion

August 1, 2013

Study Completion

March 1, 2015

Last Updated

February 29, 2016

Record last verified: 2016-02

Locations

JP(7)