Trial Outcomes & Findings for A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer (NCT NCT03042611)

Last Updated: 2022-07-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

460 participants

Primary outcome timeframe

Day 1 (randomization) up to approximately 36 months

Results posted on

2022-07-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	Extension Phase: Rivoceranib Plus BSC Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Extension Phase: 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.
Core Phase STARTED	308	152	0	0
Core Phase Received at Least 1 Dose of Study Drug	307	151	0	0
Core Phase COMPLETED	52	28	0	0
Core Phase NOT COMPLETED	256	124	0	0
Extension Phase STARTED	0	0	52	28
Extension Phase COMPLETED	0	0	0	0
Extension Phase NOT COMPLETED	0	0	52	28

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	Extension Phase: Rivoceranib Plus BSC Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Extension Phase: 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.
Core Phase Withdrawal by Subject	13	4	0	0
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
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

A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=308 Participants 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.	Placebo Plus BSC n=152 Participants 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.	Total n=460 Participants Total of all reporting groups
Age, Continuous	60.03 years STANDARD_DEVIATION 11.11 • n=93 Participants	59.96 years STANDARD_DEVIATION 10.63 • n=4 Participants	60.01 years STANDARD_DEVIATION 10.94 • n=27 Participants
Sex: Female, Male Female	67 Participants n=93 Participants	40 Participants n=4 Participants	107 Participants n=27 Participants
Sex: Female, Male Male	241 Participants n=93 Participants	112 Participants n=4 Participants	353 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	303 Participants n=93 Participants	152 Participants n=4 Participants	455 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	207 Participants n=93 Participants	105 Participants n=4 Participants	312 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	100 Participants n=93 Participants	46 Participants n=4 Participants	146 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=308 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=152 Participants 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.
Overall Survival (OS)	5.82 Months Interval 5.26 to 6.47	5.13 Months Interval 4.47 to 6.24

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=308 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=152 Participants 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.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	2.83 Months Interval 2.07 to 3.52	1.77 Months Interval 1.71 to 1.84

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=308 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=152 Participants 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.
Objective Response Rate (ORR) Per RECIST 1.1	6.5 Percentage of Participants Interval 3.74 to 9.25	1.3 Percentage of Participants Interval 0.16 to 4.67

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=308 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=152 Participants 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.
Disease Control Rate (DCR)	40.3 Percentage of Participants Interval 34.78 to 45.74	13.2 Percentage of Participants Interval 7.78 to 18.53

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=207 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=99 Participants 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.
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	-18.01 units on a scale Standard Deviation 26.80

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=207 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=99 Participants 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.
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	9.43 units on a scale Standard Deviation 35.01
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	16.50 units on a scale Standard Deviation 24.91
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	13.75 units on a scale Standard Deviation 21.91
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 24.80	8.31 units on a scale Standard Deviation 21.73
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	17.76 units on a scale Standard Deviation 22.89
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	10.55 units on a scale Standard Deviation 26.91
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	11.56 units on a scale Standard Deviation 29.15
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	14.48 units on a scale Standard Deviation 30.18
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	-18.69 units on a scale Standard Deviation 30.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=207 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=98 Participants 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.
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	-15.36 units on a scale Standard Deviation 21.61

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rivoceranib Plus Best Supportive Care (BSC) n=308 Participants Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.	Placebo Plus BSC n=152 Participants 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.
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	52 Participants
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	13 Participants
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	36 Participants
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	26 Participants
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	19 Participants
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	6 Participants
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	52 Participants
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	26 Participants
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	36 Participants
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	25 Participants
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	8 Participants
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	5 Participants
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	52 Participants
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	13 Participants
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	9 Participants
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	27 Participants
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	27 Participants
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	23 Participants
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	17 Participants
Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility: Unable	8 Participants	6 Participants
Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Mobility: Missing	100 Participants	52 Participants
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	54 Participants
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	22 Participants
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	10 Participants
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	7 Participants
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	7 Participants
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	52 Participants
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	24 Participants
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	36 Participants
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	18 Participants

Adverse Events

Rivoceranib Plus Best Supportive Care (BSC)

Serious events: 149 serious events

Other events: 299 other events

Deaths: 283 deaths

Placebo Plus BSC

Serious events: 66 serious events

Other events: 140 other events

Deaths: 134 deaths

Serious adverse events

Other adverse events

Additional Information

Elevar Clinical Trials

Elevar Therapeutics, Inc

Phone: (801) 303-7440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place