Status:
COMPLETED
Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ
Lead Sponsor:
Amgen
Conditions:
Part 1- Advanced Solid Tumors
Part 2- Advanced or Metastatic Gastric Cancer
Eligibility:
All Genders
20-100 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Key
- 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)
- Key
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01791374
Start Date
November 1 2012
End Date
March 1 2015
Last Update
February 29 2016
Active Locations (7)
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1
Research Site
Nagoya, Aichi-ken, Japan, 464-8681
2
Research Site
Kashiwa-shi, Chiba, Japan, 277-8577
3
Research Site
Matsuyama, Ehime, Japan, 791-0280
4
Research Site
Sapporo, Hokkaido, Japan, 060-8648