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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

Primary Purpose

Lung Cancer, Small Cell Lung Cancer, Solid Tumors

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

AMG 479

Etoposide

Placebo

AMG 102

Carboplatin

Cisplatin

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Extensive disease, Extrathoracic metasasis, Malignant pericardial effusion, Malignant pleural effusion, Contralateral hilar adenopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

ARM B

ARM C

ARM A

Arm Description

Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide

Blinded placebo and carboplatin or cisplatin and etoposide

Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide

Outcomes

Primary Outcome Measures

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

Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs). Part 2: Overall survival (OS)

Secondary Outcome Measures

Incidence of adverse events and laboratory abnormalities not defined as DLTs.

Incidence of anti-AMG 479 and anti-AMG 102 antibody formation

Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479)

ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months

EORTC QLQ-C30 and EORTC QLQ-LC13 scores

Full Information

NCT ID

NCT00791154

First Posted

October 23, 2008

Last Updated

October 26, 2016

Sponsor

NantCell, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00791154

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NantCell, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Extensive-stage Small Cell Lung Cancer

Keywords

Extensive disease, Extrathoracic metasasis, Malignant pericardial effusion, Malignant pleural effusion, Contralateral hilar adenopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM B

Arm Type

Active Comparator

Arm Description

Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide

Arm Title

ARM C

Arm Type

Placebo Comparator

Arm Description

Blinded placebo and carboplatin or cisplatin and etoposide

Arm Title

ARM A

Arm Type

Active Comparator

Arm Description

Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide

Intervention Type

Drug

Intervention Name(s)

AMG 479

Intervention Description

AMG 479 is administered to subjects

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

Etoposide is administered to subjects

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo is administered with Carboplatin and Etoposide

Intervention Type

Drug

Intervention Name(s)

AMG 102

Intervention Description

AMG 102 is administered to subjects

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Carboplatin is administered to some subjects in combination

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin is administered to some subjects in combination

Primary Outcome Measure Information:

Title

Time Frame

Length of study

Title

Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs). Part 2: Overall survival (OS)

Time Frame

Length of study

Secondary Outcome Measure Information:

Title

Incidence of adverse events and laboratory abnormalities not defined as DLTs.

Time Frame

Length of study

Title

Incidence of anti-AMG 479 and anti-AMG 102 antibody formation

Time Frame

Length of study

Title

Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479)

Time Frame

Length of study

Title

ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months

Time Frame

Length of study

Title

EORTC QLQ-C30 and EORTC QLQ-LC13 scores

Time Frame

Length of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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