A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors
Condition: Metastases, Neoplasm; Carcinoma, Non-small Cell Lung; Renal Cell Carcinoma; Neuroendocrine Tumors
MeSH terms: Carcinoma; Neoplasm Metastasis; Carcinoma, Renal Cell; Neuroendocrine Tumors; Carcinoma, Non-Small-Cell Lung
Intervention: LY2584702; Erlotinib; Everolimus
Intervention description: Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.; Supplied as 25 mg, 100 mg, or 150 mg tablets, administered orally, daily for two 28-day cycles.
Starting dose is 150mg. Doses may be decreased in 50mg increments if necessary due to toxicity.; Supplied as 5 mg or 10 mg tablets, administered orally, daily for two 28-day cycles.
Intervention MeSH terms: Everolimus; Erlotinib Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancer; Metastatic Cancer; Non-Small Cell Lung Cancer; Renal Cell Carcinoma; Neuroendocrine Tumors

Summary:

      Study I3G-MC-JGCB (JGCB) is a multicenter, nonrandomized, open-label, dose-escalation Phase
      1b study of LY2584702 in combination with either erlotinib or everolimus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dose Escalation portion (Part 1): have histological or cytological evidence of a
             diagnosis of cancer that is advanced and/or metastatic disease (including
             Non-Hodgkin's Lymphoma) for which no proven effective therapy exists.

          -  Dose Confirmation portion (Part 2): have histological or cytological evidence of:

               1. Arm A: advanced or metastatic non-small cell lung cancer after failure of at
                  least one prior chemotherapy regimen.

               2. Arm B: advanced renal cell carcinoma after failure of treatment with sunitinib or
                  sorafenib, or advanced neuroendocrine tumors.

          -  Have the presence of measurable or nonmeasurable disease as defined by the Response
             Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for
             Malignant Lymphoma.

               1. Dose Escalation portion (Part 1): participants may have measurable or
                  nonmeasurable disease.

               2. Dose Confirmation portion (Part 2): participants must have measurable disease.

          -  Have adequate organ function including:

               1. Hematologic: absolute neutrophil count (ANC) greater than or equal to 1.5 x
                  10⁹/liters (L), platelets greater than or equal to 100 x 10⁹/L, and hemoglobin
                  greater than or equal to 8 grams/deciliter (g/dL).

               2. Hepatic: bilirubin less than or equal to 1.5 times upper limits of normal (ULN);
                  alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to
                  2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling less than
                  or equal to 5 times ULN are acceptable. Participants with bone metastases may
                  enter with alkaline phosphatase values less than or equal to 5 times ULN, as long
                  as other hepatic parameters meet inclusion criteria.

               3. Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated
                  creatinine clearance >45 milliliter/minute (ml/mn).

          -  Have a performance status of less than or equal to 1 on the Eastern Cooperative
             Oncology Group (ECOG) scale.

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at
             least 2 weeks (3 weeks for myelosuppressive agents) prior to study enrollment, and
             have recovered from the acute effects of therapy. At the discretion of the
             investigator, participants with prostate cancers progressing under luteinizing
             hormone-releasing hormone (LHRH) agonists therapy, and participants with adrenal
             carcinomas using mitotane, may have that treatment continued while receiving study
             drug.

        Exclusion Criteria:

          -  Have received treatment with a drug that has not received regulatory approval for any
             indication within 14 or 21 days of the initial dose of study drug for a
             nonmyelosuppressive or myelosuppressive agent, respectively.

          -  Have serious preexisting medical conditions that, in the opinion of the investigator,
             would preclude participation in this study.

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants
             with treated CNS metastases are eligible provided their disease is radiographically
             stable and asymptomatic, and they are not currently receiving corticosteroids and/or
             anticonvulsants. Screening of asymptomatic participants without history of CNS
             metastasis is not required.

          -  Concomitant treatment by strong cytochrome P450 (CYP) 3A4 inhibitors or CYP3A4
             inducers.

          -  Have an acute or chronic leukemia.

          -  Have received an autologous or allogeneic stem-cell transplant within 75 days of the
             initial dose of study drug. In addition, recipients of an allogeneic stem-cell
             transplant must have discontinued immunosuppressive therapy at least 24 hours before
             study drug administration with no more than Grade 1 acute graft-versus-host disease.

          -  For Dose Confirmation portion (Part 2): have previously received erlotinib for Arm A
             or everolimus for Arm B.