A Study of Enzastaurin and Erlotinib in Patients With Solid Tumors and Lung Cancer
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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 |
- 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 ]
- 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: | September 2013 |
| 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 |
Inclusion Criteria:
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).
- 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 patient 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 patient must have recovered from acute toxic effects (except alopecia) prior to enrollment.
- Non-measurable or measurable disease as defined by RECIST.
Exclusion Criteria:
Patients 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.
Contacts and 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 | |
| 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: | June 5, 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 June 18, 2013