Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Neuroblastoma

Esthesioneuroblastoma, Olfactory

Disease Attributes

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Olfactory Nerve Diseases

Cranial Nerve Diseases

Olfactory Neuroblastoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Particpants will take rivoceranib by mouth 1 time each day while on study.

Rivoceranib

Luana Guimaraes De Sousa, MD

To learn if rivoceranib can help to control olfactory neuroblastoma. The safety of this drug in participants with olfactory neuroblastoma will also be studied.

Primary Objective:

- To assess the efficacy of rivoceranib in patients with R/M ONB

Secondary Objective:

* To estimate the median duration of response (DOR)
* Time to response
* To estimate the median progression-free survival (PFS)
* To estimate the median overall survival (OS)
* To assess safety of rivoceranib

Tertiary Objective:

- To explore biomarkers that may predict response to therapy

A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Elevar Therapeutics

M.D. Anderson Cancer Center

Digestive System Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Stomach Cancer

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Participants will receive oral daily doses of rivoceranib per 28-day cycle (as its mesylate salt) with a fixed dose of paclitaxel given intravenously on Day 1, Day 8, and Day 15 of the 28-day cycle.

Min-Hee Ryu, Dr.

This is an open-label, single-center, single-arm, dose escalation and dose expansion Phase I/IIa study designed to determine the recommended Phase 2 dose (RP2D) and the safety and tolerability profile along with preliminary signs of efficacy of rivoceranib in combination with paclitaxel as a second-line therapy in advanced, recurrent and/or metastatic gastric or gastroesophageal junction cancer. This study will also characterize the pharmacokinetic (PK) parameters of rivoceranib and paclitaxel when given in combination.

Primary Phase I Objectives

* To determine the RP2D dose of rivoceranib in combination with paclitaxel.

Primary Phase II Objectives

* To determine clinical activity of the combination of rivoceranib and paclitaxel.

Secondary Phase I Objectives

* To evaluate the PK of rivoceranib and paclitaxel when given in combination.
* To assess the efficacy of rivoceranib in combination with paclitaxel.

Secondary Phase II Objectives

* To assess the efficacy of rivoceranib in combination with paclitaxel.
* To assess the safety and tolerability of rivoceranib in combination with paclitaxel.
* To assess the PK of rivoceranib and paclitaxel when given in combination.

A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

The number and proportion of participants experiencing DLTs will be reported by dose level, based on DLT observations during Cycle 1. Each Cycle is 28 days.

An AE is any untoward medical occurrence in a participant or participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the other outcomes listed above.

ORR is the percentage of participants who achieve objective tumor response (complete response \[CR\] or partial response \[PR\]) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for response.

Defined as time from first dose of study drug (Cycle 1 Day 1) to the time of first documented disease progression or death due to any cause.

OS is the time from first dose of study drug (Cycle 1 Day 1) to the time of death from any cause.

DCR is defined as the percentage of participants who achieve CR or PR and stable disease (SD) at ≥12 weeks.

Defined as the time from first documentation of (complete response or partial response) to the first documentation of progression.

DCR is defined as the percentage of participants who achieve CR or PR and SD at ≥12 weeks.

Adverse Events and Serious Adverse Events

Ctrough is characterized at steady state after single and multiple cycles of treatment.

Carcinoma, Adenoid Cystic

Adenoid Cystic Carcinoma

Participants will receive an oral dose of rivoceranib once per day during 28-day cycles.

The purpose of this study is to evaluate the efficacy and safety of rivoceranib in adult participants with recurrent or metastatic ACC. All participants may remain on treatment until occurrence of disease progression, unacceptable toxicity, death, the withdrawal of consent from treatment, lost to follow-up or study termination by the Sponsor. When a participant discontinues rivoceranib for any reason, the participant will enter the 24 month survival follow up period until withdrawal of consent from the study, lost to follow up, end of the study or death, whichever occurs earlier.

The maximum duration of the study is estimated to be 48 months and includes screening, treatment, and follow-up phases.

A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)

A Phase 2 Open-Label, Multicenter, Study to Evaluate the Efficacy and Safety of Rivoceranib in Subjects With Recurrent or Metastatic Adenoid Cystic Carcinoma of All Anatomic Sites of Origin

ORR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator/institutional assessment.

ORR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Independent Central Review.

DoR per RECIST 1.1 by investigator/institutional assessment.

DoR per RECIST 1.1 by Independent Central Review.

PFS per RECIST 1.1 by investigator/institutional assessment.

PFS per RECIST 1.1 by Independent Central Review.

TTP per RECIST 1.1 by investigator/institutional assessment.

TTP per RECIST 1.1 by Independent Central Review.

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Immune Checkpoint Inhibitors

Sorafenib

Camrelizumab at 200 mg via intravenous administration (IV), once every 2 weeks (Q2W), in combination with 250 mg of rivoceranib mesylate, oral administration, once a day (QD)

camrelizumab；Rivoceranib

Sorafenib tosylate (400 mg, twice a day (BID), po)

Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)

Regorafenib

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (HCC)

Randomized，Open，Controlled, International Multi-Center

A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)

A Randomized, Open-Label, Controlled, International Multi-Center Phase III Clinical Study of Camrelizumab Combined With Rivoceranib (Apatinib) Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Hepatocellular Carcinoma (HCC) Who Have Been Treated With Immune Checkpoint Inhibitors (ICIs)

Jiangsu HengRui Medicine Co., Ltd.

Esophageal Neoplasms

Stomach Diseases

Esophageal Cancer

Participants will receive rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.

Participants will receive matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.

Placebo

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).

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

A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib Plus Best Supportive Care (BSC) Compared to Placebo Plus BSC in Patients With Advanced or Metastatic Gastric Cancer

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.

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.

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.

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.

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.

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.

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.

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.

The Safety set consisted of data from all participants in the ITT set who received at least 1 dose of rivoceranib or placebo. In the Safety set, participants were included in the group based on the treatment that was received. Safety data was analyzed by the Safety set which includes participants who were alive and on treatment or in OS follow-up. All-Cause Mortality includes deaths that led to study discontinuation and deaths that occurred during safety follow up.

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.

Rivoceranib Plus Best Supportive Care (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.

Placebo Plus 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.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The Intent to Treat (ITT) set consists of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.

Elevar Clinical Trials

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.

Overall Survival (OS)

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.

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Objective Response Rate (ORR) Per RECIST 1.1

Disease Control Rate (DCR)

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.

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)

Body Image

Dyspnea

Pain

Reflux Symptoms

Eating Restrictions

Anxiety

Dry Mouth

Taste

Hair Loss

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.

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score

Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score

Mobility: No problems

Mobility: Slight problems

Mobility: Moderate problems

Mobility: Severe problems

Mobility: Unable

Mobility: Missing

Self Care: No problems

Self Care: Slight problems

Self Care: Moderate problems

Self Care: Severe problems

Self Care: Unable

Self Care: Missing

Usual Activities: No problems

Usual Activities: Slight problems

Usual Activities: Moderate problems

Usual Activities: Severe problems

Usual Activities: Unable

Usual Activities: Missing

Pain/Discomfort: No pain or discomfort

Pain/Discomfort: Slight pain or discomfort

Pain/Discomfort: Moderate pain or discomfort

Pain/Discomfort: Severe pain or discomfort

Pain/Discomfort: Extreme pain or discomfort

Pain/Discomfort: Missing

Anxiety/Depression: Not anxious or depressed

Anxiety/Depression: Slightly anxious or depressed

Anxiety/Depression: Moderately anxious or depressed

Anxiety/Depression: Severely anxious or depressed

Anxiety/Depression: Extremely anxious or depressed

Anxiety/Depression: Missing

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma	NCT06308575	Metastatic Olfa... Recurrent Olfac...	Rivoceranib	18 Years -	M.D. Anderson Cancer Center
A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer	NCT03707028	Gastric Cancer Gastroesophagea...	Rivoceranib Paclitaxel	19 Years -	Elevar Therapeutics
A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)	NCT04119453	Adenoid Cystic ...	Rivoceranib	18 Years -	Elevar Therapeutics
A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)	NCT04985136	Advanced Hepato...	camrelizumab；Ri... Rivoceranib Sorafenib Regorafenib	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer	NCT03042611	Gastric Cancer Gastric Adenoca...	Rivoceranib Placebo	18 Years -	Elevar Therapeutics
A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer	NCT03707028	Gastric Cancer Gastroesophagea...	Rivoceranib Paclitaxel	19 Years -	Elevar Therapeutics
A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)	NCT04985136	Advanced Hepato...	camrelizumab；Ri... Rivoceranib Sorafenib Regorafenib	18 Years -	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for rivoceranib

Every month we try and update this database with for rivoceranib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rivoceranib

Every month we try and update this database with for rivoceranib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rivoceranib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.