Clinical trial NCT01791374: Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ
Official title: A Multicenter, Phase 1/1b, Open Label Study Evaluating the Safety, Tolerability and Pharmacokinetics of Rilotumumab in Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Part 1- Advanced Solid Tumors
Part 2- Advanced or Metastatic Gastric Cancer
Part 2- Advanced or Metastatic GEJ
Keywords: Advanced Solid Tumors
Advanced or Metastatic Gastric Cancer
Advanced or Metastatic GEJ
Gastric Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Part1: Dose-limiting toxicities (DLT) for each dose level of rilotumumab tested
timeFrame: 28 days
measure: 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 outcomes:
measure: Part 1: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies.
timeFrame: 4 months average
measure: 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
measure: 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
measure: Part 2: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies not defined as DLTs.
timeFrame: 7 months average
measure: 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
measure: 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
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Research Site
state: Ehime
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kitaadachi-gun
country: Japan
facility: Research Site
state: Saitama
city: Suntou-gun
country: Japan
facility: Research Site
state: Shizuoka
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.