Gastric Cancer, Gastric Adenocarcinoma
Conditions
Keywords
Gastric Cancer, Gastric Adenocarcinoma, Gastro-esophageal Cancer, Gastro-esophageal Junction Cancer, Stomach Cancer, Tumor, Oncology, Antiangiogenesis, Metastatic
Brief summary
The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best supportive care (BSC) compared to placebo plus BSC in participants with advanced or metastatic gastric cancer (GC).
Interventions
DRUGRivoceranib
Oral tablet
DRUGPlacebo
Oral tablet
Sponsors
Elevar Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction. 2. Locally advanced unresectable or metastatic disease that has progressed since last treatment. 3. One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). 4. Failure or intolerance to at least 2 prior lines of standard chemotherapies with each containing one or more of the following agents: * fluoropyrimidine (intravenous \[IV\] 5-fluorouracil \[5-FU\] capecitabine, or S-1), * platinum (cisplatin or oxaliplatin), * taxanes (paclitaxel or docetaxel) or epirubicin, * irinotecan, * trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive, * ramucirumab * nivolumab * pembrolizumab 5. Disease progression within 6 months after the last treatment. 6. Adequate bone-marrow, renal and liver function. 7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. 8. Expected survival of ≥12 weeks, in the opinion of the investigator.
Exclusion criteria
1. History of another malignancy within 2 years prior to randomization except for the following: Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (CIS); Curatively treated cervical CIS; Thyroid papillary cancer with prior treatment; Carcinoma of the skin without melanomatous features; Prostate cancer which had been surgically or medically treated and not likely to recur within 2 years. 2. Central nervous system (CNS) metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization. 3. Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 1 week in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.). 4. Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the participant at risk. 5. Participants who had therapeutic paracentesis of ascites (\>1 Liter \[L\]) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (\>1L) within 3 months of starting study treatment. 6. Previous treatment with rivoceranib. 7. Known hypersensitivity to rivoceranib or components of the formulation. 8. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Day 1 (randomization) up to approximately 36 months | OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 24 months | PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored. |
| Objective Response Rate (ORR) Per RECIST 1.1 | Up to approximately 24 months | ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to \<10 millimeter \[mm\]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1. |
| Disease Control Rate (DCR) | Up to approximately 24 months | DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1. |
| Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EOT (Month 24) | EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response. |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Baseline, EOT (Up to 24 months) | EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden. |
| Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score | Baseline, EOT (Up to 24 months) | EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. |
| Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline, End of Treatment (EOT) (Up to 24 months) | EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden. |
Countries
France, Germany, Italy, Japan, Poland, Romania, Russia, South Korea, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
Participants were randomized to receive either rivoceranib +best supportive care (BSC) or placebo +BSC for approximately 24 months. Participants who benefited from rivoceranib were permitted to continue rivoceranib during an extension period of the study, up to approximately 36 months. Participants in the extension period were followed for survival status only. Only participants whose reason for study discontinuation was death are included. See the AE module for All-Cause Mortality Deaths.
Participants by arm
| Arm | Count |
|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) Participants received rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. | 308 |
| Placebo Plus BSC Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. | 152 |
| Total | 460 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Core Phase | Death | 232 | 110 | 0 | 0 |
| Core Phase | Lost to Follow-up | 4 | 7 | 0 | 0 |
| Core Phase | Physician Decision | 7 | 2 | 0 | 0 |
| Core Phase | Study Closed | 0 | 1 | 0 | 0 |
| Core Phase | Withdrawal by Subject | 13 | 4 | 0 | 0 |
| Extension Phase | Death | 0 | 0 | 34 | 16 |
| Extension Phase | Lost to Follow-up | 0 | 0 | 1 | 1 |
| Extension Phase | Study Closed | 0 | 0 | 17 | 11 |
Baseline characteristics
| Characteristic | Placebo Plus BSC | Total | Rivoceranib Plus Best Supportive Care (BSC) |
|---|---|---|---|
| Age, Continuous | 59.96 years STANDARD_DEVIATION 10.63 | 60.01 years STANDARD_DEVIATION 10.94 | 60.03 years STANDARD_DEVIATION 11.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants | 455 Participants | 303 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 105 Participants | 312 Participants | 207 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 46 Participants | 146 Participants | 100 Participants |
| Sex: Female, Male Female | 40 Participants | 107 Participants | 67 Participants |
| Sex: Female, Male Male | 112 Participants | 353 Participants | 241 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 283 / 307 | 134 / 151 |
| other Total, other adverse events | 299 / 307 | 140 / 151 |
| serious Total, serious adverse events | 149 / 307 | 66 / 151 |
Outcome results
Primary
Overall Survival (OS)
OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored.
Time frame: Day 1 (randomization) up to approximately 36 months
Population: The ITT set for the OS final analysis consisted of data from all participants who were randomized, including participants who were still in OS follow-up at the time of primary analysis. In the ITT set, participants were included in the group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Overall Survival (OS) | 5.82 Months |
| Placebo Plus BSC | Overall Survival (OS) | 5.13 Months |
Secondary
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score
EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden.
Time frame: Baseline, EOT (Up to 24 months)
Population: The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline, number of participants analyzed indicates number of participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Dyspnea | 16.64 units on a scale | Standard Deviation 26.34 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Anxiety | 13.69 units on a scale | Standard Deviation 23.64 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Reflux Symptoms | 11.46 units on a scale | Standard Deviation 24.8 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Dry Mouth | 20.77 units on a scale | Standard Deviation 33.22 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Pain | 12.72 units on a scale | Standard Deviation 23.96 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Taste | 15.30 units on a scale | Standard Deviation 32.46 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Eating Restrictions | 18.12 units on a scale | Standard Deviation 26.45 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Hair Loss | -15.37 units on a scale | Standard Deviation 33.71 |
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Body Image | 11.71 units on a scale | Standard Deviation 29.95 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Hair Loss | -18.69 units on a scale | Standard Deviation 30.05 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Body Image | 9.43 units on a scale | Standard Deviation 35.01 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Dyspnea | 16.50 units on a scale | Standard Deviation 24.91 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Pain | 13.75 units on a scale | Standard Deviation 21.91 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Reflux Symptoms | 8.31 units on a scale | Standard Deviation 21.73 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Eating Restrictions | 17.76 units on a scale | Standard Deviation 22.89 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Anxiety | 10.55 units on a scale | Standard Deviation 26.91 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Dry Mouth | 11.56 units on a scale | Standard Deviation 29.15 |
| Placebo Plus BSC | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | Taste | 14.48 units on a scale | Standard Deviation 30.18 |
Secondary
Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score
EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time frame: Baseline, EOT (Up to 24 months)
Population: The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score | -18.48 units on a scale | Standard Deviation 19.11 |
| Placebo Plus BSC | Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score | -15.36 units on a scale | Standard Deviation 21.61 |
Secondary
Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden.
Time frame: Baseline, End of Treatment (EOT) (Up to 24 months)
Population: The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | -17.51 units on a scale | Standard Deviation 22.72 |
| Placebo Plus BSC | Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | -18.01 units on a scale | Standard Deviation 26.8 |
Secondary
Disease Control Rate (DCR)
DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1.
Time frame: Up to approximately 24 months
Population: The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Disease Control Rate (DCR) | 40.3 Percentage of Participants |
| Placebo Plus BSC | Disease Control Rate (DCR) | 13.2 Percentage of Participants |
Secondary
Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response.
Time frame: EOT (Month 24)
Population: The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Slight problems | 61 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: No problems | 100 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Moderate problems | 56 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Not anxious or depressed | 49 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Severe problems | 43 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Slight problems | 47 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Unable | 12 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Severe problems | 43 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Missing | 100 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Moderate problems | 40 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: No pain or discomfort | 25 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Slight problems | 60 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Slight pain or discomfort | 61 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Severe problems | 14 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Moderate pain or discomfort | 67 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Unable | 8 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Severe pain or discomfort | 47 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Unable | 7 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Extreme pain or discomfort | 8 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: No problems | 46 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Missing | 100 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Slightly anxious or depressed | 60 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Missing | 100 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Moderately anxious or depressed | 62 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Missing | 100 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Severely anxious or depressed | 29 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Extremely anxious or depressed | 8 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: No problems | 36 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Missing | 100 Participants |
| Rivoceranib Plus Best Supportive Care (BSC) | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Moderate problems | 51 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Missing | 52 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Not anxious or depressed | 26 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Severely anxious or depressed | 8 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: No problems | 27 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Slight problems | 27 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Moderate problems | 23 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Severe problems | 17 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Unable | 6 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Mobility: Missing | 52 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: No problems | 54 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Slight problems | 22 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Moderate problems | 10 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Severe problems | 7 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Unable | 7 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Self Care: Missing | 52 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: No problems | 24 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Slight problems | 36 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Moderate problems | 18 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Severe problems | 13 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Unable | 9 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Usual Activities: Missing | 52 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: No pain or discomfort | 13 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Slight pain or discomfort | 36 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Moderate pain or discomfort | 26 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Severe pain or discomfort | 19 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Extreme pain or discomfort | 6 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Slightly anxious or depressed | 36 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Moderately anxious or depressed | 25 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Anxiety/Depression: Extremely anxious or depressed | 5 Participants |
| Placebo Plus BSC | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Pain/Discomfort: Missing | 52 Participants |
Secondary
Objective Response Rate (ORR) Per RECIST 1.1
ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to \<10 millimeter \[mm\]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1.
Time frame: Up to approximately 24 months
Population: The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Objective Response Rate (ORR) Per RECIST 1.1 | 6.5 Percentage of Participants |
| Placebo Plus BSC | Objective Response Rate (ORR) Per RECIST 1.1 | 1.3 Percentage of Participants |
Secondary
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored.
Time frame: Up to approximately 24 months
Population: The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rivoceranib Plus Best Supportive Care (BSC) | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 2.83 Months |
| Placebo Plus BSC | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 1.77 Months |