Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Lung Neoplasms

Carcinoma, Renal Cell

Neuroendocrine Tumors

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Renal Cell Carcinoma

Neuroendocrine Tumor

Clear Cell Renal Cell Carcinoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Everolimus

Erlotinib Hydrochloride

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Tyrosine Kinase Inhibitors

Tyrosine

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.

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.

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

LY2584702

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.

Erlotinib

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

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)

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.

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

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

The recommended dose for the Phase 2 (Dose Confirmation Phase) study was determined by safety assessment. Doses were escalated following the assessment for toxicity based on Common Terminology Criteria for Adverse Events (CTCAE v4.0). Any adverse events (AE) that were possibly related to LY2584702 were considered toxicities. The Phase 2 dose of LY2584702 was not determined due to unacceptable toxicities of LY2584702 in combination with erlotinib or everolimus in Phase 1 of the study.

Clinically significant events were defined as serious adverse events (SAEs) and other non-SAEs regardless of causality. A summary of serious and other non SAEs regardless of causality is located in the Reported Adverse Event module.

PFS was defined as the time from the date of enrollment to the date of objectively determined progressive disease (PD) or death whichever comes first. Censoring of PFS was defined as participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective assessment; for participants who received subsequent systematic anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, PFS was censored at the date of the last objective progression-free disease assessment prior to post discontinuation of therapy. PFS was not analyzed due to different tumor types and different doses.

Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.

AUC from time 0 to 8 hours (AUC0-8) and AUC from time 0 to infinity (AUC0-∞).

BOR was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of LD of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.

Eli Lilly and Company

Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.

50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for 2 28-day cycles.

Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD

50 mg LY2584702 administered orally twice daily BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.

Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD

100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.

Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD

75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.

Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD

50 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.

Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD

100 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.

Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD

50 mg LY2584702 administered orally BID plus 150 mg everolimus administered orally QD for 2 28-day cycles.

Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD

50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.

50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.

100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.

75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.

50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.

100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.

50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

France

Region of Enrollment

Participants received at least 1 dose of study drug.

Study terminated early. Dose confirmation, Part B, was not initiated.

Chief Medical Officer

Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.

LY2584702 + Erlotinib

Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.

LY2584702+Everolimus

All participants who received at least 1 dose of study drug.

Recommended Dose for Phase 2 Studies

SAEs

Non-SAEs

Clinically Significant Effects (Number of Participants With Adverse Events)

Zero participants were analyzed as no data collected.

Progression-Free Survival (PFS)

50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 2 28-day cycles.

Arm A - 50 mg LY2584702 (BID) + 150 mg Erlotinib QD

All participants who received at least 1 dose of study drug and assessed for RR.

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]

C1 D1, single dose

C1 D8, steady state

50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.

All participants who received at least 1 dose of study drug and had Cmax values.

Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702

AUC0-8, D1, single dose

AUC0-8, D8, steady state

AUC0-∞, D1, single dose

All participants who received at least 1 dose of study drug and had AUC values.

Pharmacokinetics, Area Under the Concentration Time Curve (AUC)

All participants who received at least 1 dose of study drug and assessed for BOR.

Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]

Participants who received at least 1 dose of study drug.

Spots Global Cancer Trial Database for A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial