NCT00415363

Brief Summary

This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

Typical duration for phase_2

Geographic Reach
5 countries

7 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

Study Start

First participant enrolled

December 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

4.1 years

First QC Date

December 20, 2006

Results QC Date

October 9, 2020

Last Update Submit

October 9, 2020

Conditions

Non Small Cell Lung CancerSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to Progression of Brain Metastases

    Time to progression (TTP) of brain metastases is the time from randomization to first observation of brain metastases progression. Response Evaluation Criteria In Solid Tumors (RECIST; Version 1.0), using magnetic resonance imaging (MRI), until observation of objective progression, or clinically as the date of increased steroids dose (barring radiological confirmation), was used to assess progressive disease (PD) of brain metastases. TTP was right-censored with the date of last contact if the participant died without MRI-documented PD or symptomatic deterioration or was lost to follow-up or received post therapy (Radio, Systemic, Surgery) before documented PD of the brain metastases.

    Baseline to measured progressive disease (up to 21.2 months)

Secondary Outcomes (11)

  • Time to Objective Progression of Brain Metastases

    Baseline to measured progressive disease (up to 21.2 months)

  • Overall Progression-free Survival (Including Both Progression of Brain and Extracranial Tumor Lesion)

    Baseline to measured progressive disease (up to 14.4 months)

  • Overall Survival

    Baseline to date of death from any cause (up to 27.2 months)

  • Overall Response (OR) to Treatment of Extra-cranial Tumor Lesions by Percentage of Participants

    Baseline to measured progressive disease (up to 27.2 months)

  • Best Overall Tumor Response on Brain Metastases by Percentage of Participants

    Baseline to measured progressive disease (up to 21.2 months)

  • +6 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: enzastaurin

B

PLACEBO COMPARATOR
Drug: placebo

Interventions

enzastaurinDRUG

1125 mg loading dose then 500 mg, oral, daily, until disease progression

Also known as: LY317615
A
placeboDRUG

oral, daily

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having radiologically proven brain metastases of lung cancer
  • Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. Treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
  • No other previous radiotherapy to the brain except for radiosurgery at one occasion
  • Adequate organ function as measured by appropriate laboratory tests.
  • Age 18 years or older.

You may not qualify if:

  • Inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
  • Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
  • Concurrent administration of warfarin
  • Hemophilia
  • Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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.

Copenhagen, 2100, Denmark

Location

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.

Bergen, 5021, Norway

Location

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.

Trondheim, 7006, Norway

Location

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.

Olsztyn, 10-228, Poland

Location

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.

Cluj-Napoca, 3400, Romania

Location

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.

Gothenburg, 41345, Sweden

Location

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.

Umeå, 90185, Sweden

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 5, 2020

Results First Posted

November 5, 2020

Record last verified: 2020-10

Locations

SE(2)PL(1)RO(1)DK(1)NO(2)