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

Phase 1

Completed

• Conditions: Part 1- Advanced Solid Tumors; Part 2- Advanced or Metastatic Gastric Cancer; Part 2- Advanced or Metastatic GEJ
• Interventions: Drug: Rilotumumab

• Registration Number: NCT01791374
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Primary Completion: 2013-08
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rilotumumab plus CX	Rilotumumab	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
Rilotumumab Monotherapy	Rilotumumab	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

Primary Outcome Measures

Name	Time	Method
Part1: Dose-limiting toxicities (DLT) for each dose level of rilotumumab tested	28 days	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.
Part 2: Dose-limiting toxicities (DLT) for each dose level of rilotumumab in combination with cisplatin and capecitabine (CX) chemotherapy tested	21 days	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.

Secondary Outcome Measures

Name	Time	Method
Part 1: Incidence of AEs, clinical laboratory abnormalities and anti-rilotumumab antibodies.	4 months average	AEs and laboratory abnormalities are reported by CTCAE (version 3.0) criteria
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	AEs and laboratory abnormalities are reported by CTCAE (version 3.0) criteria
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
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.	7 months average

Trial Locations

Locations (1)

Research Site; 🇯🇵 Suntou-gun, Shizuoka, Japan