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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastases, Neoplasm Carcinoma, Non-small Cell Lung Renal Cell Carcinoma Neuroendocrine Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: LY2584702 + Erlotinib

Participants received 50 mg LY2584702 once daily (QD )+ 150 mg Erlotinib QD, 50 mg LY2584702 twice daily (BID) + 150 mg Erlotinib QD, 100 mg LY2584702 BID + 150 mg Erlotinib QD and 75 mg LY2584702 BID + 150 mg Erlotinib QD.

Group Type EXPERIMENTAL

LY2584702

Intervention Type DRUG

Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.

Erlotinib

Intervention Type DRUG

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.

Arm B: LY2584702 + Everolimus

Participants received 50 mg LY2584702 QD + 10 mg Everolimus QD, 100 mg LY2584702 QD + 10 mg Everolimus QD and 50 mg LY2584702 BID + 10 mg Everolimus QD.

Group Type EXPERIMENTAL

LY2584702

Intervention Type DRUG

Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.

Everolimus

Intervention Type DRUG

Supplied as 5 mg or 10 mg tablets, administered orally, daily for two 28-day cycles.

Interventions

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LY2584702

Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.

Intervention Type DRUG

Erlotinib

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.

Intervention Type DRUG

Everolimus

Supplied as 5 mg or 10 mg tablets, administered orally, daily for two 28-day cycles.

Intervention Type DRUG

Eligibility Criteria

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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).
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No