QUILT-2.013: A Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Amgen Protocol 20060534 - A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791154
• Other study ID #: 20060534
• Secondary ID: QUILT-2.013
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 23, 2008
• Last updated: October 26, 2016
• Start date: December 2008
• Est. completion date: February 2013

Study information

• Verified date: October 2016
• Source: NantCell, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: University of Santo Tomas Hospital Institutional Review BoardPoland: Central Ethics CommitteeRomania: National Agency for Medicines and Medical DevicesSouth Korea: Korea Food & Drug AdministrationSpain: Comite Etico de Investigacion ClinicaSpain: reference Ethics CommitteeTaiwan: Taiwan Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationUnited States: Western Institutional Review BoardRussia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)Russia: Ministry of Health of the Russian FederationBelgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: Local Ethics Committees for each involved site ( 6 Local EC)France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Central EC, called Comite de Protection des PersonnesHungary: National Institute of PharmacyIndia: Central India Medical Research Ethics CommitteeIndia: Human Ethics CommitteeIndia: Kidwai Memorial Institute of Oncology Institutional Ethics CommitteeIndia: National Health & Education Society IECIndia: SEAROC Ethics CommitteeItaly: Local Ethics CommitteesItaly: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO)Philippines: Ethics Review Committee, Baguio General Hospital and Medical CenterPhilippines: St. Luke's Medical Center Institutional Ethics Review Board
• Study type: Interventional

Clinical Trial Summary

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: February 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

• Histologically or cytologically confirmed SCLC

• Extensive disease, defined by at least one of the following:

• No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)

• Extrathoracic metastases

• Malignant pericardial or pleural effusion

• Contralateral hilar adenopathy

• Measurable or nonmeasurable disease, as defined by modified RECIST

• Eastern Cooperative Oncology Group (ECOG) status 0 or 1

• =18 years old

• Life expectancy (with therapy) =3 months

• Adequate hematologic, hepatic, coagulation, renal, and metabolic function

• Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) = 8% and fasting glucose levels =160 mg/dL

Key Exclusion Criteria

• Prior chemotherapy, chemoradiation, or investigational agent for SCLC

• Prior radiotherapy to >25% of the bone marrow

• Symptomatic or untreated central nervous system metastases (with exceptions)

• Currently or previously treated with biologic, immunologic or other therapies for SCLC

• Current serious or nonhealing wound or ulcer

• History of prior concurrent other malignancy (with exceptions)

• Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI

• Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity

Study Design

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

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Solid Tumors

Intervention

Drug:
• AMG 479
AMG 479 is administered to subjects
• Etoposide
Etoposide is administered to subjects
• Placebo
Placebo is administered with Carboplatin and Etoposide
• AMG 102
AMG 102 is administered to subjects
• Carboplatin
Carboplatin is administered to some subjects in combination
• Cisplatin
Cisplatin is administered to some subjects in combination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NantCell, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 2: To estimate the relative treatment effect of platinum-based chemotherapy and AMG 479, and of platinum-based chemotherapy and AMG 102, compared to platinum-based chemotherapy and placebo as measured by the respective HR for overall survival		Length of study	No
Primary	Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs). Part 2: Overall survival (OS)		Length of study	No
Secondary	Incidence of adverse events and laboratory abnormalities not defined as DLTs.		Length of study	No
Secondary	Incidence of anti-AMG 479 and anti-AMG 102 antibody formation		Length of study	No
Secondary	Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479)		Length of study	No
Secondary	ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months		Length of study	No
Secondary	EORTC QLQ-C30 and EORTC QLQ-LC13 scores		Length of study	No

External Links

•   AmgenTrials clinical trials website