A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534027
• Other study ID #: 20060295
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 20, 2007
• Last updated: December 14, 2015
• Start date: January 2008
• Est. completion date: March 2011

Study information

• Verified date: December 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationBelgium: Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCanada: Health CanadaSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Disease Related

• Histologically or cytologically confirmed non-small cell lung cancer.

• Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.

• Planning to receive up to 6 cycles of chemotherapy

• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic

• Men or women > 18 years of age Ethical

• Adequate Hematological, renal, hepatic and coagulation function General

• Plan to begin protocol specific therapy < 7 days after enrollment/randomization

Exclusion Criteria:

• Disease Related

• Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.

• Prior chemotherapy as follows:

• Any prior chemotherapy for advanced non-small cell lung cancer

• Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.

• Any prior chemoradiation.

• Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization

• Other abnormal medical conditions

• Documented myocardial infarction or unstable/uncontrolled cardiac condition

• History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders

• Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• AMG 655
AMG 655 is a monoclonal antibody directed against TR-2.

Other:
• AMG 655 placebo
Inactive dummy AMG 655 (to maintain blind)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		Until disease progression	No
Secondary	Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities		Until disease progression	No

External Links

•   AmgenTrials clinical trials website