Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Lenvatinib

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with Everolimus in participants with unresectable advanced or metastatic RCC.

Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)

Phase 1 Study of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic RCC

DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).

BOR included complete response (CR), partial response (PR), stable disease (SD), and PD (progressive disease). BOR was assessed using Response Evaluation Criteria in Solid Tumor (RECIST) 1.1

ORR was defined as the percentage of participants who achieved BOR of CR or PR. ORR was assessed using RECIST 1.1.

DCR was defined as the percentage of participants who achieved BOR of CR, PR, or SD. DCR was assessed based on RECIST 1.1.

Eisai Co., Ltd.

Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue withdrawal of consent, or study termination by sponsor (up to 23 cycles).

Lenvatinib 18 mg + Everolimus 5 mg

Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The safety analysis set was the group of participants who received at least 1 dose of lenvatinib.

Eisai Medical Services

The DLT analysis set was the group of participants who had completed treatment Cycle 1 without major protocol deviation with a treatment compliance of at least 75 percent (%) and had been assessed for DLT, and participants who had experienced DLT during Cycle 1.

Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)

TEAE

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Lenvatinib: Cycle 1 Day 1

Everolimus: Cycle 1 Day 1

The pharmacokinetic (PK) analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated.

Cmax: Maximum Observed Plasma Concentration for Levatinib and Everolimus

Lenvatinib: Cycle 1 Day 15

Everolimus: Cycle 1 Day 15

The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.

Css,Max: Maximum Observed Plasma Concentration at Steady State for Levatinib and Everolimus

The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated.

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Levatinib and Everolimus

Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for Levatinib and Everolimus

The PK analysis set was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.

AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus

The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.

Number of Participants With Best Overall Response (BOR)

Objective Response Rate (ORR)

Disease Control Rate (DCR)

Less than or equal to (<=) -30%

Greater than (>) -30% to less than (<) 20%

Greater than or equal to (>=) 20%

Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions

Participants received lenvatinib 18 milligram (mg) capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).

Overall Study

Spots Global Cancer Trial Database for Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial