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

Amgen

Status and phase: Completed; Phase 1

Conditions: Part 2- Advanced or Metastatic GEJ; Part 1- Advanced Solid Tumors; Part 2- Advanced or Metastatic Gastric Cancer

Treatments: Drug: Rilotumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01791374

20110251 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Rilotumumab Monotherapy

Experimental group

Description:

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

Treatment:

Drug: Rilotumumab

Drug: Rilotumumab

Rilotumumab plus CX

Experimental group

Description:

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

Treatment:

Drug: Rilotumumab

Drug: Rilotumumab