AzTrials
AzTrials

Gastric CancerPhase 3ANGELNCT03042611

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

A Phase 3 study testing Rivoceranib in people with Gastric Cancer and Gastric Adenocarcinoma, run by Elevar Therapeutics at 95 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Gastric Adenocarcinoma
What is being tested?
Rivoceranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
95 sitesin 12 countries
Study dates
14 Mar 2017to 23 Sep 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction.
  • Locally advanced unresectable or metastatic disease that has progressed since last treatment.
  • One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  • 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),
Show all 16Show fewer
  • taxanes (paclitaxel or docetaxel) or epirubicin,
  • irinotecan,
  • trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive,
  • ramucirumab
  • nivolumab
  • pembrolizumab
  • Disease progression within 6 months after the last treatment.
  • Adequate bone-marrow, renal and liver function.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  • Expected survival of ≥12 weeks, in the opinion of the investigator.

Who cannot join

  • 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.
  • 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.
  • 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.).
  • 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.
  • 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.
  • Previous treatment with rivoceranib.
  • Known hypersensitivity to rivoceranib or components of the formulation.
  • Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.

Trial locations and contacts

95 sites in 12 countries.

95 sites in 12 countries

South Korea22 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14069

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Chungbuk National University Medical Center

    Chuncheon, 41404

  • Kyungpook National University Medical Center

    Daegu, 41404

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Yeungnam University Medical Center

    Daegu, 42415

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Gachon University Gil Medical Center

    Incheon, 21555

  • Chungbuk National University Hospital

    Jungbuk, 54907

  • Korea University Anam Hospital

    Seoul, 02841

  • Severence Hospital, Yonsei University Health System

    Seoul, 03722

  • Veterans Health Service (VHS) Medical Center

    Seoul, 05368

  • ASAN Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

  • Ajou University Hospital

    Suwon, Gyonggi-do, 16499

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Japan15 sites

  • Chiba Cancer Center

    Chiba, Chiba City, 260-8717

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • National Hospital Organization Shikoku Cancer Center

    Ehime, Matsuyama, 791-0280

  • Kyushu University Hospital

    Fukuoka, Higashi-ku, 812-8582

  • Japan Community Health Care Organization Kyushu Hospital

    Fukuoka, Kitakyushu-shi, 806-8501

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • Hyogo Cancer Center

    Hyōgo, Akasi-city, 673-0021

  • St. Marianna University School of Medicine Hospital

    Kanagawa, Kawasaki-shi, 216-8511

  • Saku Central Hospital Advanced Care Center

    Nagano, Saku-shi, 385-0051

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

  • Osaka University Hospital

    Osaka, Suita, 565-0871

  • Saitama Cancer Center

    Saitama, Kitaadachi-gun, 362-0806

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Tokyo, Koto-ku, 135-8550

  • Keio University Hospital

    Tokyo, Shinjuku-ku, 160-8582

Other trials in Japan

Italy10 sites

  • Magna Graecia University- Department of Experimental and Clinical Medicine

    Catanzaro, 88100

  • U.O Di Oncologia Ospedale Degli Infermi

    Faenza, 48018

  • Fondazione IRCCS-Istituto Nazionale Tumori

    Milan, 20133

  • Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia.

    Modena, 41124

  • Veneto Oncology Institute (IOV-IRCCS), Melanoma & Esophageal Oncology Unit

    Padova, 35128

  • Ospedale di Piacenza - Oncology and heamatology

    Piacenza, 29121

  • Ospedale "Felice Lotti"

    Pontedera, 56025

  • IRCCS/Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • Rimini Hospital

    Rimini, 47923

  • Ospedali Riuniti di Ancona - SOD Clinica Oncologica

    Torrette, 60126

Other trials in Italy

Ukraine9 sites

  • Dnipropetrovsk Medical Academy, Department of Oncology

    Dnipro, 49102

  • Communal Institution "Ivano-Frankivsk Regional Oncological Center"

    Ivano-Frankivsk, 76000

  • Communal Institution "Kharkiv Regional Clinical Oncology Center ", Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology

    Kharkiv, 61070

  • Kherson Regional Oncological Dispensary

    Kherson, 73035

  • Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department

    Kryvyi Rih, 50048

  • Municipal Institution "Kyiv City Clinical Oncological Center"

    Kyiv, 03115

  • Communal Institution "Transcarpathian Regional Clinical Oncological Center"

    Uzhhorod, 88014

  • Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"

    Vinnytsia, 21029

  • State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine", Department of oncology based on Municipal Institution "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly

    Zaporizhzhya, 69040

Other trials in Ukraine

Russia8 sites

  • State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

    Arkhangelsk, 163045

  • State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"

    Kursk, 305035

  • Omsk regional clinical oncology center

    Omsk, 644013

  • Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"

    Oryol, 302020

  • State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"

    Pyatigorsk, 357502

  • Federal State Budgetary Educational Institution of Higher Education "Academician I.P. Pavlov First St. Petersburg State Medical University" of the Ministry of Heaithcare of the Russian Federation

    Saint Petersburg, 197022

  • Ogarev Mordovia State University

    Saransk, 430032

  • State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"

    Ufa, 450054

Other trials in Russia

Taiwan8 sites

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, Niaosong Dist, 83301

  • Kaohsiung Medical University Hospital

    Kaohsiung City, Sanmin Dist, 80708

  • China Medical University Hospital

    Taichung, Taichung City, 40447

  • Chi Mei Medical Center - LiouYing Branch

    Tainan, Liuying DIst, 736

  • National CHeng Kung University Hospital

    Tainan, Tainan City, 70403

  • Taipei Veterans General Hospital

    Taipei, Beitou Dist, 11217

  • National Taiwan University Hospital

    Taipei, Zhongzheng Dist, 100

  • Chang Gung Memorial Hospital - Linko Branch

    Taoyuan, Kuei Shan Hsiang, 333

Other trials in Taiwan

United States5 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Hudson Valley Cancer Centre

    Hawthorne, New York, 10532

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Mayo Clinic Phoenix

    Scottsdale, Arizona, 85259

Other trials in United States

France5 sites

  • Centre Hospitalier Franco-Britannique; Oncologie Médicale

    Levallois-Perret, 92300

  • Centre Leon-Berard (CLB)

    Lyon, 69008

  • Institut Regional du Cancer Montpellier (ICM)

    Montpellier, 34298

  • Centre Antoine-Lacassagne

    Nice, 06189

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany4 sites

  • Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie

    Berlin, 13353

  • "Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt

    Frankfurt, 60488

  • Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 20249

  • Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie

    Marburg, 35043

Other trials in Germany

Romania4 sites

  • Saint Constantin Hospital (TEO HEALTH SA)

    Brasov, 500091

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I

    Cluj-Napoca, 400015

  • S.C. Medisprof S.R.L.

    Cluj-Napoca, 400058

  • Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala

    Craiova, 200347

Other trials in Romania

United Kingdom3 sites

  • Royal Marsden Hospital London

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Royal Marsden Hospital Surrey

    Sutton, SM2 5PT

Other trials in United Kingdom

Poland2 sites

  • Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii

    Krakow, 31-501

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: 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

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).

Being tested
Rivoceranib, Placebo
Keywords
Gastric Cancer, Gastric Adenocarcinoma, Gastro-esophageal Cancer, Gastro-esophageal Junction Cancer, Stomach Cancer, Tumor, Oncology, Antiangiogenesis, Metastatic
Medical subject headings
Stomach Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivoceranibDrug

    Also called Apatinib

    Oral tablet

  • PlaceboDrug

    Oral tablet

Study groups in NCT03042611
Study groupRoleWhat they receive
Rivoceranib Plus BSCExperimentalParticipants 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.
Receives: Drug: Rivoceranib
PlaceboExperimentalParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 (randomization) up to approximately 36 months

Secondary outcomes (7)

  1. 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.

    Measured: Up to approximately 24 months

  2. 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.

    Measured: Up to approximately 24 months

  3. 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.

    Measured: Up to approximately 24 months

  4. 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.

    Measured: Baseline, End of Treatment (EOT) (Up to 24 months)

  5. 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.

    Measured: Baseline, EOT (Up to 24 months)

  6. 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.

    Measured: Baseline, EOT (Up to 24 months)

  7. 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.

    Measured: EOT (Month 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study start14 Mar 2017
  3. Primary completion15 Feb 2019
  4. Study completion23 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03042611
Sponsor's protocol ID
LSK-AM301
Acronym
ANGEL
Status last verified
Jun 2022
First submitted
24 Jan 2017
Last updated
8 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivoceranib in people with Gastric Cancer and Gastric Adenocarcinoma, run by Elevar Therapeutics at 95 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in South Korea, Japan, Italy, Ukraine, Russia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Day 1 (randomization) up to approximately 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03042611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
ANGEL Clinical Trial NCT03042611 | AzTrials