Brief Summary

Phase I: A study to see what doses of Enzastaurin and Erlotinib are best tolerated by participants with solid tumor cancer. Phase II: A study to see how long participants with non-small cell lung cancer (NSCLC) treated with Enzastaurin and Erlotinib live.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer

Timeline

Completed

Started May 2007

Longer than P75 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach

1 country

10 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

6.5 years study duration

First Submitted

Initial submission to the registry

March 23, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed

1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed

4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed

7.5 years until next milestone

Results Posted

Study results publicly available

May 13, 2021

Completed

Last Updated

May 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

March 23, 2007

Results QC Date

April 20, 2021

Last Update Submit

April 20, 2021

Conditions

Non-Small Cell Lung Cancer Malignant Solid Tumor

Outcome Measures

Primary Outcomes (2)

Recommended Phase 2 Dose for Enzastaurin Plus Erlotinib Combination Therapy (Assess the Tolerated Dose of the Combination Erlotinib and Enzastaurin)
The recommended Phase 2 daily dose level was to be either 1 dose level below that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs) in Phase 1 or the full doses of both enzastaurin and erlotinib (Phase 1, Dose Level 2) in the event that no more than 1 DLT occurred at the highest dose level (Dose Level 2). DLTs were defined as any of the following events during Phase 1, Cycle 1 that were considered by the investigator to be attributable to enzastaurin or the combination of enzastaurin with erlotinib: Grade 4 hematologic events; Grade 3 or 4 nonhematologic events except toxicities explained by a coexisting condition such as glucose disturbances in a diabetic or electrolyte imbalances from diarrhea or vomiting, and toxicities of nausea, vomiting, diarrhea, or skin rash that were tolerable with appropriate treatment.
Phase 1: Predose through end of Cycle 1 (28 days/cycle)
Phase 2: Progression-Free Survival (PFS) With the Enzastaurin Plus Erlotinib Combination Regimen
PFS was defined as the time from the date of study enrollment (baseline) to the first date of progressive disease (PD) (either objectively determined or clinical progression) or death from any cause. PD was defined by Response Evaluation Criteria in Solid Tumors \[RECIST, version (v) 1.0\] as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who did not have PD, PFS was censored at the date of the last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post discontinuation anticancer therapy.
Phase 2: Baseline to measured PD (up to 20 months)

Secondary Outcomes (8)

Phase I: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) (Safety and AE Profile for Enzastaurin/Erlotinib Combination)
Phase 1: First dose through 30 days post last dose (up to 14 Cycles, 28 days/cycle)
Phase I: Pharmacokinetic (PK) Interactions Between Enzastaurin and Erlotinib: Apparent Oral Clearance of Erlotinib Under Steady State Conditions During Multiple Dosing (CLss/F)
Phase 1: Cycle 1, Day 22 [predose, 2 hours (h), 4 h, 6 h, 10 h postdose]
Phase I: PK Interactions Between Enzastaurin and Erlotinib: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
Phase 1: Cycle 1, Day 22 (predose, 2 h, 4 h, 6 h, 8 h postdose)
Phase I: PK Interactions Between Enzastaurin and Erlotinib: Area Under the Plasma Concentration Time Curve at Steady State [AUC(Tau,ss)]
Phase 1, Cycle 1, Day 22 (predose, 2 h, 4 h, 6 h, and 8 h postdose)
Phase 2: Overall Survival (OS)
Phase 2: Baseline to date of death from any cause (up to 23 months)
+3 more secondary outcomes

Study Arms (1)

Enzastaurin and erlotinib combination therapy

EXPERIMENTAL

Enzastaurin: * Phase 1, Dose Level 1: 500 milligram (mg) oral loading dose Day 1, 250 mg oral, daily Day 2-28, 28-day cycle until disease progression * Phase 1, Dose Level 2: 1125 mg oral loading dose Day 1, 500 mg oral, daily until disease progression * Phase 2: Dose determined from Phase 1, oral, daily, 28-day cycles until disease progression Erlotinib: • 150 mg, oral, daily, 28-day cycles until disease progression

Drug: enzastaurinDrug: erlotinib

Interventions

enzastaurinDRUG

Administered orally

Also known as: LY317615

Enzastaurin and erlotinib combination therapy

erlotinibDRUG

Administered orally

Enzastaurin and erlotinib combination therapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Phase 1: Any incurable solid malignancy, with no more than 3 prior systemic treatment regimens.
Phase 2: Histologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV per American Joint Committee on Cancer Staging Criteria for NSCLC. Participants must have failed 1 or 2 prior systemic treatment regimen(s).
Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale
Prior chemotherapy must be completed at least 2 weeks prior to study enrollment, and the participant must have recovered from acute toxic effects (except alopecia) prior to enrollment.
Prior radiotherapy is allowed to \<25% of the bone marrow. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the participant must have recovered from acute toxic effects (except alopecia) prior to enrollment.
Non-measurable or measurable disease as defined by Response Evaluation Criteria in Solid Tumors \[RECIST, version (v) 1.0\].

You may not qualify if:

Participants who
Are unable to swallow tablets.
Unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
Have previously been treated with an epidermal growth factor receptor (EGFR) inhibitor, including erlotinib.
Are receiving concurrent administration of any other antitumor therapy.
Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (10)

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

Palo Alto, California, 94305, United States

Location

San Francisco, California, 94143, United States

Location

Louisville, Kentucky, 40207, United States

Location

Baltimore, Maryland, 21237, United States

Location

Minneapolis, Minnesota, 55455, United States

Location

Omaha, Nebraska, 68131, United States

Location

Portland, Oregon, 97213, United States

Location

Memphis, Tennessee, 38104, United States

Location

Lubbock, Texas, 79410, United States

Location

Related Publications (1)

Padda SK, Krupitskaya Y, Chhatwani L, Fisher GA, Colevas AD, San Pedro-Salcedo M, Decker R, Latz JE, Wakelee HA. A phase I dose-escalation and pharmacokinetic study of enzastaurin and erlotinib in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Apr;69(4):1013-20. doi: 10.1007/s00280-011-1792-8. Epub 2011 Dec 11.
PMID: 22160298DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

enzastaurinErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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 - 5PM 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 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 27, 2007

Study Start

May 1, 2007

Primary Completion

July 1, 2009

Study Completion

November 1, 2013

Last Updated

May 13, 2021

Results First Posted

May 13, 2021

Record last verified: 2021-04

Locations

US(10)

A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

Enzastaurin and erlotinib combination therapy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

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 (2)

Secondary Outcomes (8)

Study Arms (1)

Enzastaurin and erlotinib combination therapy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations