A Multicenter, Phase 1/1b, Open Label Study Evaluating the Safety, Tolerability and Pharmacokinetics of Rilotumumab in Japanese Subjects
20 Years
N/A
Both
Part 1- Advanced Solid Tumors, Part 2- Advanced or Metastatic Gastric Cancer, Part 2- Advanced or Metastatic GEJ
Trial Information
A Multicenter, Phase 1/1b, Open Label Study Evaluating the Safety, Tolerability and Pharmacokinetics of Rilotumumab in Japanese Subjects
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 (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 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Part1: Dose-limiting toxicities (DLT) for each dose level of rilotumumab tested
Outcome Description:
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.
Outcome Time Frame:
28 days
Safety Issue:
Yes
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
20110251
NCT ID:
NCT01791374
Start Date:
November 2012
Completion Date:
April 2015
Related Keywords:
- Part 1- Advanced Solid Tumors
- Part 2- Advanced or Metastatic Gastric Cancer
- Part 2- Advanced or Metastatic GEJ
- Advanced Solid Tumors
- Advanced or Metastatic Gastric Cancer
- Advanced or Metastatic GEJ
- Gastric Cancer
- Stomach Neoplasms
- Neoplasms
Name | Location |
|---|
