NCT01107444|CompletedPhase 2Results

Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Were Previously Treated With First Line Chemotherapy

Eli Lilly and Company ClinicalTrials.gov

Compare

3 other identifiers

11766H8Z-MC-JACW2009-017591-24

Study Type

interventional

Target

180

Locations

6 countries

Sites

Timeline

RegisteredApr 2010

StartedMay 2010

CompletionJun 2012

Brief Summary

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

180

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline

Completed

Started May 2010

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach

6 countries

36 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

April 15, 2010

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed

10 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed

7 years until next milestone

Results Posted

Study results publicly available

May 24, 2019

Completed

Last Updated

September 11, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

April 15, 2010

Results QC Date

March 11, 2019

Last Update Submit

August 28, 2019

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Tumor Size to the End of Cycle 2
The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. The log ratio of tumor size at the end of Cycle 2 to tumor size at baseline was calculated for each participant.
Baseline, End of Cycle 2 (1 cycle = 21 days)

Secondary Outcomes (12)

Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding
Randomization through long-term follow up (up to 21.6 months)
Progression Free Survival (PFS)
Randomization to the first date of progressive disease or death from any cause (up to 12.88 months)
Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel
Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4 hours(h);LY2181308 + Docetaxel: C1 D-1:3,4 h;D1:0,3,4 h
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel
Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4,5,505,513,2521 hours(h);LY2181308 + Docetaxel: C1 D -1:3,4 h;D1:0,3,4,5,5.25,5.75,7,8,120,504,507,509,1008,1512,1515,1517,2016, 2520,2523,2525 h
Overall Survival (OS)
Randomization to date of death from any cause (up to 21.6 months)
+7 more secondary outcomes

Study Arms (2)

LY2181308 + Docetaxel

EXPERIMENTAL

LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met. Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.

Drug: DocetaxelDrug: LY2181308

Docetaxel

ACTIVE COMPARATOR

Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.

Drug: Docetaxel

Interventions

DocetaxelDRUG

Administered intravenously

DocetaxelLY2181308 + Docetaxel

LY2181308DRUG

Administered intravenously

LY2181308 + Docetaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
Measureable disease as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Must make available any existing tumor tissue from the primary biopsy
Participants with prior radiation may be eligible if they meet certain criteria
Adequate bone marrow reserve and organ functioning
Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period and must not be breastfeeding
Men must comply with a contraceptive regimen during and for 6 months after the treatment period

You may not qualify if:

Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Participants may be permitted to enter treatment before the 30 day waiting period in special circumstances
Pregnant or breastfeeding
Serious concomitant systemic disorders that would compromise the safety of the participant or the participant's ability to complete the study
Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
Participants with documented central nervous system or brain metastasis at the time of study entry
Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (36)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Los Angeles, California, 90048, United States

Location

Tampa, Florida, 33612, United States

Location

Chicago, Illinois, 60612, United States

Location

Detroit, Michigan, 48201, United States

Location

Minneapolis, Minnesota, 55455, United States

Location

Lebanon, New Hampshire, 03756, United States

Location

New York, New York, 10032, United States

Location

Charleston, South Carolina, 29425, United States

Location

Madison, Wisconsin, 53705, United States

Location

Brussels, 1200, Belgium

Location

Edegem, 2650, Belgium

Location

Leuven, 3000, Belgium

Location

Braunschweig, 38114, Germany

Location

Hamburg, 22527, Germany

Location

Hanover, 30625, Germany

Location

Heidelberg, 69126, Germany

Location

Karlsruhe, 76137, Germany

Location

Mannheim, 68167, Germany

Location

Münster, 48149, Germany

Location

Ulm, 89081, Germany

Location

Aviano, 33081, Italy

Location

Genova, 16132, Italy

Location

Lido di Camaiore, 55043, Italy

Location

Orbassano, 10043, Italy

Location

Pisa, 56100, Italy

Location

Rome, 00168, Italy

Location

Gdansk, 80-952, Poland

Location

Poznan, 60-569, Poland

Location

Szczecin-Zdunowo, Poland

Location

Warsaw, 02-781, Poland

Location

London, England, SE1 9RT, United Kingdom

Location

Nottingham, Nottinghamshire, NG5 1PD, United Kingdom

Location

Headington, Oxford, OX3 7LJ, United Kingdom

Location

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Sheffield, Trent, S10 2SJ, United Kingdom

Location

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

Natale R, Blackhall F, Kowalski D, Ramlau R, Bepler G, Grossi F, Lerchenmuller C, Pinder-Schenck M, Mezger J, Danson S, Gadgeel SM, Summers Y, Callies S, Andre V, Das M, Lahn M, Talbot D. Evaluation of antitumor activity using change in tumor size of the survivin antisense oligonucleotide LY2181308 in combination with docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study. J Thorac Oncol. 2014 Nov;9(11):1704-8. doi: 10.1097/JTO.0000000000000285.
PMID: 25436803DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DocetaxelLY 2181308

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 21, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

September 11, 2019

Results First Posted

May 24, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US(9)PL(4)BE(3)GB(6)DE(8)IT(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

LY2181308 + Docetaxel

Docetaxel

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (36)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations