| Primary | Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment | DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (>=) 7 days or Grade 3 neutropenia with fever (greater than [>] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting >7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for >7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization. | The safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. Here, overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Count of Participants | | Participants | | Cycle 1 (Cycle length= 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG002 | Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg | Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 300 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG003 | Cohort 4: Lenvatinib 20 mg + Golvatinib 400 mg | Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 400 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Primary | Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib | The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0. | The safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. | Posted | | Number | | milligram per day (mg/day) | | Cycle 1 (Cycle length= 28 days) | | | | ID | Title | Description |
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| OG000 | All Cohorts: Golvatinib + Lenvatinib | Eligible participants from single agent run-in period, received lenvatinib 12 mg or 20 mg capsules, orally, once daily in combination with golvatinib 200 mg or 300 mg or 400 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Primary | Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib | The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0. | The safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. | Posted | | Number | | mg/day | | Cycle 1 (Cycle length= 28 days) | | | | ID | Title | Description |
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| OG000 | All Cohorts: Lenvatinib + Golvatinib | Eligible participants from single agent run-in period, received lenvatinib 12 mg or 20 mg capsules, orally, once daily in combination with golvatinib 200 mg or 300 mg or 400 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment | | The safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. | Posted | | Count of Participants | | Participants | | From baseline up to approximately 5 years 5 months | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG002 | Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg |
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| Secondary | Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment | | The safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. | Posted | | Count of Participants | | Participants | | From baseline up to approximately 5 years 5 months | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG002 | Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg |
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| Secondary | Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment | | The safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. | Posted | | Count of Participants | | Participants | | From baseline up to approximately 5 years 5 months | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG002 | Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg | |
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| Secondary | Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment | | The safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. | Posted | | Count of Participants | | Participants | | From baseline up to approximately up to 5 years 5 months | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG002 | Cohort 3: Lenvatinib 20 mg + Golvatinib 300 mg |
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| Secondary | Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7 | | The pharmacokinetic (PK) analysis set included participants who had at least 1 evaluable plasma concentration. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Day -7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. | Posted | | Mean | Standard Deviation | ng/mL | | Day -8: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. | Posted | | Median | Full Range | hours | | Day -7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. | Posted | | Median | Full Range | hours | | Day -8: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here, overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | nanogram*hour per milliliter(ng*h/mL) | | Day -7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. | Posted | | Mean | Standard Deviation | ng*h/mL | | Day -8: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. | Posted | | Mean | Standard Deviation | ng*h/mL | | Day -7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8 | | PK analysis set included participants who had at least 1 evaluable plasma concentration. | Posted | | Mean | Standard Deviation | ng*h/mL | | Day -8: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7 | | PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | ng*h/mL | | Day -7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here, overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | ng*h/mL | | Day -8: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | hours | | Day-7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8 | | PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | hours | | Day -8: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | liter per hour (L/h) | | Day -7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | liter per hour (L/h) | | Day -8: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | liter (L) | | Day -7: 0-24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | liter (L) | | Day -8: 0-24 hours post dose | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1 | | PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points. | Posted | | Mean | Standard Deviation | ng/mL | | Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points. | Posted | | Median | Full Range | hours | | Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2 | | PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Median | Full Range | hours | | Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1 | | PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points. | Posted | | Mean | Standard Deviation | ng*h/mL | | Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | ng*h/mL | | Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points. | Posted | | Mean | Standard Deviation | ng*h/mL | | Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | ng*h/mL | | Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. | Posted | | Mean | Standard Deviation | liter per hour (L/h) | | Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points. | Posted | | Mean | Standard Deviation | ratio | | Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2 | | The PK analysis set included participants who had at least 1 evaluable plasma concentration. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points. | Posted | | Mean | Standard Deviation | ratio | | Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Participants received lenvatinib 12 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 | Cohort 2: Lenvatinib 20 mg + Golvatinib 200 mg | Participants received lenvatinib 20 mg capsules, orally, once on Day -8, followed by golvatinib 200 mg tablets, orally, once on Day -7 in single agent run in period. Eligible participants who completed run-in period were then entered in combination agent treatment period. In combination agent treatment period, participants received lenvatinib 20 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). |
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| Secondary | Phase 1b: Objective Response Rate (ORR); Combination Treatment | ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Safety analysis set (combination treatment) included all participants who received at least 1 dose of combination treatment and had at least 1 postbaseline safety evaluation. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months) | | | | ID | Title | Description |
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| OG000 | Cohort 1: Lenvatinib 12 mg + Golvatinib 200 mg | Eligible participants from single agent run-in period, received lenvatinib 12 mg capsules, orally, once daily in combination with golvatinib 200 mg tablets, orally, once daily in 28-days treatment cycles in combination agent treatment period until disease progression, development of unacceptable toxicity, or withdrawal of consent (up to approximately 88 weeks). | | OG001 |
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