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

Not Recruiting

Trial ID: NCT00452413


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.

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


Inclusion Criteria:

   1. Phase 1: Any incurable solid malignancy, with no more than 3 prior systemic treatment

   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)

   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


drug: enzastaurin

drug: erlotinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Melanie San Pedro-Salcedo

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