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



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/2/2016
Start Date:May 2007
End Date:November 2013

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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 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.


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. Participants 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 participant 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 participant must have
recovered from acute toxic effects (except alopecia) prior to enrollment.

5. Non-measurable or measurable disease as defined by Response Evaluation Criteria in
Solid Tumors [RECIST, version (v) 1.0].

Exclusion Criteria:

Participants 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.
We found this trial at
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