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Study Complete
Sponsor ID
20110251

Phase 1/1b Study of Rilotumumab in Japanese Subjects with Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ

Sponsor ID
20110251
Clinicaltrials.gov ID
NCT01791374
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 1
Product
AMG 102
Type
Interventional
Masking
None (Open Label)
Enrollment
21
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 28 days

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

Timeframe: 21 days

Secondary Outcome Measures

Part 1: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies.

Timeframe: 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.

Timeframe: 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.

Timeframe: 4 months average

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

Timeframe: 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.

Timeframe: 7 months average

Part 2: Evaluate efficacy based on the treatment effects of rilotumumab in combination with cisplatin and capecitabine as measured by the following: Objective Response Rate, duration of response, progression-free survival, overall survival.

Timeframe: 7 months average

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
Location
Research Site
Suntou-gun, Shizuoka, Japan, 411-8777
Status
Recruiting
Location
Research Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Status
Recruiting
Location
Research Site
Kitaadachi-gun, Saitama, Japan, 362-0806
Status
Recruiting
Location
Research Site
Matsuyama-shi, Ehime, Japan, 791-0280
Status
Recruiting
Location
Research Site
Nagoya-shi, Aichi, Japan, 464-8681
Status
Completed
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Study Info
Age
20 - 100 Years
Condition
  • Solid Tumor
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  • Gastrointestinal Cancer
    • Sex
    All
    Trial Dates
    Nov 2012 - Aug 2013
    Inclusion and Exclusion Criteria
    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 (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)
    Exclusion Criteria:
    - 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