A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors



Status:Terminated
Conditions:Lung Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:March 2010
End Date:June 2011

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A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors

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.

Study JGCB will consist of the following parts:

Part 1 - Dose Escalation to maximum tolerated dose in each arm.

Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic cancer.

Arm B - LY2584702 + Everolimus in participants with advanced or metastatic cancer.

Part 2 - Dose Confirmation of maximum tolerated dose from each arm in Part 1.

Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic non-small cell lung
cancer.

Arm B - LY2584702 + Everolimus in participants with advanced renal cell carcinoma after
treatment failure with sunitinib or sorafenib, or advanced neuroendocrine tumors.

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.
We found this trial at
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