Colorectal CancerPhase 2NCT00612586

Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer

A Phase 2 study testing Enzastaurin, Leucovorin (LV) and 5-fluorouracil (5-FU) in people with Colorectal Cancer, run by Eli Lilly and Company at 26 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: Enzastaurin, Leucovorin (LV) and 5-fluorouracil (5-FU)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 117 participants
Where: 26 sitesin 6 countries
Study dates: Feb 2008to Nov 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologic diagnosis of locally advanced or metastatic colorectal cancer (CRC) that is not curable. The histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. Patients with neuroendocrine carcinomas will be excluded.
Received 6 cycles (3 months [12 weeks]) of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for metastatic CRC. Patients have received at least 5 cycles with bevacizumab. Patients who received 6 cycles of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for recurrent CRC that has relapsed at least 12 months after completion of adjuvant therapy will also be included. All standard FOLFOX (FOLFIRI) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed.
No more than 4 weeks may pass between the end of first-line therapy (that is, Day 14 of Cycle 6) and randomization.
Documented evidence of tumor response of complete response (CR), partial response (PR), or stable disease (SD) by computed tomography (CT) scan or magnetic resonance imaging (MRI). Confirmation of response is not required.

Who cannot join

Are unable to swallow tablets.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have known central nervous system metastases.
Are receiving concurrent administration of any other antitumor therapy.
Patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection

Trial locations and contacts

26 sites in 6 countries.

Country

City, postcode or hospital

26 sites in 6 countries

Germany7 sites

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.
Augsburg, D-86150
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Frankfurt, D-60431
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Heidelberg, D-69120
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Lübeck, 23562
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München, 81925
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Munich, 81377
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Weiden, 92637

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France6 sites

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Brest, 29609
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Caen, 14076
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Clichy, 92118
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Lille, 59020
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Marseille, 13385
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Paris, 75015

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Italy5 sites

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Bari, 70126
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Bergamo, 24128
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Florence, 50139
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Livorno, 57128
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Milan, 20133

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Austria4 sites

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Innsbruck, 6020
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Krems, 3500
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Salzburg, 5020
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Vienna, 1100

Other trials in Austria

United States3 sites

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Houston, Texas, 77030
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Memphis, Tennessee, 38138
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Salt Lake City, Utah, 84106

Other trials in United States

Puerto Rico1 site

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.
San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer

Conditions: Colorectal Cancer
Being tested: Enzastaurin, Placebo, Leucovorin (LV), 5-fluorouracil (5-FU), Bevacizumab (Bev)
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EnzastaurinDrug
Also called LY317615
1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease
PlaceboDrug
oral, daily (up to 1 yr or until progressive disease)
Leucovorin (LV)Drug
400 milligram per meter squared (mg/m^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
5-fluorouracil (5-FU)Drug
400 mg/m^2 bolus then 2400 mg/m^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
Bevacizumab (Bev)Drug
5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Study groups in NCT00612586
Study group	Role	What they receive
Enzastaurin + 5-FU/LV + Bev	Experimental	5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin Receives: Drug: Enzastaurin; Drug: Leucovorin (LV); Drug: 5-fluorouracil (5-FU); Drug: Bevacizumab (Bev)
Placebo + 5-FU/LV + Bev	Placebo comparator	5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo Receives: Drug: Placebo; Drug: Leucovorin (LV); Drug: 5-fluorouracil (5-FU); Drug: Bevacizumab (Bev)

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of Response Evaluation Criteria in Solid Tumor (RECIST) Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.
Measured: Randomization to measured progressive disease or death up to 17.2 months

Secondary outcomes (4)

Overall Survival (OS)
OS was the duration from enrollment to death due to any cause. For participants who are alive, OS is censored at the last contact.
Measured: Randomization up to 22.8 months
Number of Participants With Adverse Events (AEs)
A summary of serious and all other non-serious AEs is located in the Reported Adverse Event module.
Measured: Randomization up to 17.2 months
Overall Survival (OS) From Start of First Line Therapy
OS was the duration from first line therapy to death due to any cause. For participants who are alive, OS is censored at the last contact.
Measured: Start of first line therapy (approximately 3 months prior to randomization) to date of death from any cause up to 27 months post randomization
PFS From Start of First Line Therapy
PFS was defined as the time from first line therapy to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of RECIST Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.
Measured: Start of first line therapy to measured progressive disease or death up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Nov 2011

First posted11 Feb 2008 (estimated)
Study startFeb 2008
Primary completionJan 2010
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00612586
Sponsor's protocol ID: 10534
Other IDs: H6Q-MC-S064
Status last verified: Jul 2020
First submitted: 28 Jan 2008
Last updated: 21 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.
PubMed 22213153

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00612586
Acronym / sponsor ID: 10534
Conditions: Colorectal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Roche Pharma AG
Study start: Feb 2008
Primary completion: Jan 2010 (actual)
Study completion: Nov 2011 (actual)
First posted: 11 Feb 2008 (estimated)
Results: Posted 21 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Enzastaurin + 5-FU/LV + Bev	Experimental	Drug: Enzastaurin, Drug: Leucovorin (LV), Drug: 5-fluorouracil (5-FU), Drug: Bevacizumab (Bev)5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin
Placebo + 5-FU/LV + Bev	Placebo comparator	Drug: Placebo, Drug: Leucovorin (LV), Drug: 5-fluorouracil (5-FU), Drug: Bevacizumab (Bev)5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histologic diagnosis of locally advanced or metastatic colorectal cancer (CRC) that is not curable. The histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. Patients with neuroendocrine carcinomas will be excluded.
Received 6 cycles (3 months [12 weeks]) of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for metastatic CRC. Patients have received at least 5 cycles with bevacizumab. Patients who received 6 cycles of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for recurrent CRC that has relapsed at least 12 months after completion of adjuvant therapy will also be included. All standard FOLFOX (FOLFIRI) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed.
No more than 4 weeks may pass between the end of first-line therapy (that is, Day 14 of Cycle 6) and randomization.
Documented evidence of tumor response of complete response (CR), partial response (PR), or stable disease (SD) by computed tomography (CT) scan or magnetic resonance imaging (MRI). Confirmation of response is not required.

Key exclusion criteria (5 listed)

Are unable to swallow tablets.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have known central nervous system metastases.
Are receiving concurrent administration of any other antitumor therapy.
Patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EnzastaurinAlso: LY3176151125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease	Drug	Enzastaurin + 5-FU/LV + Bev
Placebooral, daily (up to 1 yr or until progressive disease)	Drug	Placebo + 5-FU/LV + Bev
Leucovorin (LV)400 milligram per meter squared (mg/m^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)	Drug	Enzastaurin + 5-FU/LV + Bev, Placebo + 5-FU/LV + Bev
5-fluorouracil (5-FU)400 mg/m^2 bolus then 2400 mg/m^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)	Drug	Enzastaurin + 5-FU/LV + Bev, Placebo + 5-FU/LV + Bev
Bevacizumab (Bev)5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)	Drug	Enzastaurin + 5-FU/LV + Bev, Placebo + 5-FU/LV + Bev

Primary outcome

Progression Free Survival (PFS)
Time frame: Randomization to measured progressive disease or death up to 17.2 months
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of Response Evaluation Criteria in Solid Tumor (RECIST) Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.

4 secondary outcomes

Overall Survival (OS)
Time frame: Randomization up to 22.8 months
Number of Participants With Adverse Events (AEs)
Time frame: Randomization up to 17.2 months
Overall Survival (OS) From Start of First Line Therapy
Time frame: Start of first line therapy (approximately 3 months prior to randomization) to date of death from any cause up to 27 months post randomization
PFS From Start of First Line Therapy
Time frame: Start of first line therapy to measured progressive disease or death up to 24 months

Results and safety

Results posted to the registry on 21 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enzastaurin + 5-FU/LV + Bev	58	15
Placebo + 5-FU/LV + Bev	59	18

Primary outcome: Progression Free Survival (PFS)

Time frame: Randomization to measured progressive disease or death up to 17.2 months. Median (95% Confidence Interval). Unit: months

Measure	Enzastaurin + 5-FU/LV + Bev n = 58	Placebo + 5FU/LV + Bev n = 59
Value	5.8 (4.4 to 7.8)	8.1 (6.8 to 12.1)

Enzastaurin + 5-FU/LV + Bev vs Placebo + 5FU/LV + Bev: p = 0.8956, Log Rank

Population analysed: Intent-to-Treat (ITT) Population: All randomized participants.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enzastaurin + 5-FU/LV Plus Bevacizumab	15 of 57 (26.3%)	53 of 57 (93%)	Not reported
Placebo + 5FU/LV + Bevacizumab	11 of 58 (19%)	52 of 58 (89.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22213153Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

26 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzastaurin, Leucovorin (LV) and 5-fluorouracil (5-FU) in people with Colorectal Cancer, run by Eli Lilly and Company at 26 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany, France, Italy, Austria, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Randomization to measured progressive disease or death up to 17.2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00612586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.