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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00452413
First received: March 23, 2007
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

Phase I: A study to see what doses of Enzastaurin and Erlotinib are best tolerated by patients with solid tumor cancer.

Phase II: A study to see how long patients with non-small cell lung cancer treated with Enzastaurin and Erlotinib live


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: enzastaurin
Drug: erlotinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Trial of Enzastaurin and Erlotinib in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer (NSCLC) After Prior Chemotherapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Phase 1: Assess the tolerated dose of the combination erlotinib and enzastaurin. [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Phase 2: Assess progression free survival with the combination regimen. [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase 1: safety and adverse event profile for enzastaurin/erlotinib combination [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Evaluate pharmacokinetic interactions between enzastaurin and erlotinib [ Time Frame: cycle 1 ] [ Designated as safety issue: No ]
  • Phase 2: overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Phase 2: duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Phase 2: tumor response [ Time Frame: baseline to measured tumor response ] [ Designated as safety issue: No ]
  • Phase 2: safety and adverse event profile [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 58
Study Start Date: May 2007
Estimated Study Completion Date: April 2014
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin

Phase 1: 500 mg oral loading dose day 1, 250 mg oral daily day 2-28, 28 day cycle until disease progression

Dose Escalation:1125 mg oral loading dose day 1, 500 mg oral daily until disease progression

Phase 2: phase 1 determined dose, oral, daily, 28 day cycles until disease progression

Other Name: LY317615
Drug: erlotinib
150 mg, oral, daily, 28 day cycles until disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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. Patients must have failed 1 or 2 prior systemic treatment regimen(s).

  2. Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale
  3. Prior chemotherapy must be completed at least 2 weeks prior to study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
  4. Prior radiotherapy is allowed to < 25% of the bone marrow Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
  5. Non-measurable or measurable disease as defined by RECIST.

Exclusion Criteria:

Patients who

  1. Are unable to swallow tablets.
  2. Unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
  3. Have previously been treated with an epidermal growth factor receptor (EGFR) inhibitor, including erlotinib.
  4. Are receiving concurrent administration of any other antitumor therapy.
  5. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452413

Locations
United States, California
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, United States, 90048
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.
Palo Alto, California, United States, 94305
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 Francisco, California, United States, 94143
United States, Kentucky
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.
Louisville, Kentucky, United States, 40207
United States, Maryland
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.
Baltimore, Maryland, United States, 21237
United States, Minnesota
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.
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
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.
Omaha, Nebraska, United States, 68131
United States, Oregon
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.
Portland, Oregon, United States, 97213
United States, Tennessee
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.
Memphis, Tennessee, United States, 38104
United States, Texas
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.
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00452413     History of Changes
Other Study ID Numbers: 11183, H6Q-MC-S030
Study First Received: March 23, 2007
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014