Phase 2
Completed N=65
A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer
Non-Small Cell Lung Cancer · Malignant Solid Tumor
Source: ClinicalTrials.gov NCT00452413 ↗
Enrolled (actual)
65
Serious AEs
33.9%
Results posted
May 2021
Primary outcomePrimary: Recommended Phase 2 Dose for Enzastaurin Plus Erlotinib Combination Therapy (Assess the Tolerated Dose of the Combination Erlotinib and Enzastaurin) — 500; 150 milligrams per day (mg/day)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Phase 2 Dose for Enzastaurin Plus Erlotinib Combination Therapy (Assess the Tolerated Dose of the Combination Erlotinib and Enzastaurin) |
500; 150 | — |
| PRIMARY Phase 2: Progression-Free Survival (PFS) With the Enzastaurin Plus Erlotinib Combination Regimen |
1.7 | — |
| SECONDARY Phase I: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) (Safety and AE Profile for Enzastaurin/Erlotinib Combination) |
4; 12 | — |
| SECONDARY Phase I: Pharmacokinetic (PK) Interactions Between Enzastaurin and Erlotinib: Apparent Oral Clearance of Erlotinib Under Steady State Conditions During Multiple Dosing (CLss/F) |
6.07; 5.75 | — |
| SECONDARY Phase I: PK Interactions Between Enzastaurin and Erlotinib: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) |
618; 1600; 431; 980; 978; 2620 | — |
| SECONDARY Phase I: PK Interactions Between Enzastaurin and Erlotinib: Area Under the Plasma Concentration Time Curve at Steady State [AUC(Tau,ss)] |
6590; 18000; 7100; 18000; 14000; 37100 | — |
| SECONDARY Phase 2: Overall Survival (OS) |
8.3 | — |
| SECONDARY Phase 2: Duration of Response |
8.7 | — |
| SECONDARY Phase 2: Percentage of Participants With Tumor Response |
0; 10.2; 20.4; 42.9; 26.5 | — |
| SECONDARY Phase 2: Number of Participants Who Experienced TEAEs (Safety and AE Profile) |
48 | — |
Eligibility Criteria
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. 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].
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00452413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.