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Adenoid Cystic CarcinomaPhase 2NCT04119453

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

A Phase 2 study testing Rivoceranib in people with Adenoid Cystic Carcinoma, run by Elevar Therapeutics at 11 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenoid Cystic Carcinoma
What is being tested?
Rivoceranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
11 sitesin 2 countries
Study dates
22 Jan 2020to 28 Jun 2023
Phase
Phase 2
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

  • Histologically or cytologically confirmed metastatic/recurrent ACC not amenable to potentially curative surgery or radiotherapy
  • Evidence of disease progression by RECIST v1.1
  • Note: Disease progression is defined as one of the following occurring within the 6 months prior to study entry:
  • At least a 20% increase in radiologically or clinically measurable lesions
  • Appearance of any new lesions
  • Presence of at least one measurable target lesion which is evaluable by RECIST v1.1 criteria
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  • Participants are eligible if central nervous system (CNS) metastases have been treated and participants are neurologically returned to baseline or neurologically stable in the opinion of Investigator (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to first dose of study drug administration. In addition, participants must be either off corticosteroids, or on a stable dose or decreasing dose of <20 milligrams (mg) daily prednisone or prednisone equivalent.
  • Note: Only participants with a known history or indication of CNS disease are required to have CNS imaging prior to study entry
  • Adequate organ and marrow function within 14 days prior to the first dose of rivoceranib administration, defined as:
  • Absolute neutrophil count ≥1500/microliters (μL)
  • Platelet count ≥100,000/μL
  • Serum bilirubin ≤1.5× upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN (≤5.0×ULN, if with liver metastasis)
  • Estimated Creatinine Clearance >50 milliliters (mL)/minute (min) (Cockcroft-Gault)
  • Partial thromboplastin time (PTT), prothrombin time (PT) and international normalized ratio (INR) ≤1.5×ULN
  • Hemoglobin ≥9.0 grams (g)/deciliter (dL)
  • Urinary protein <2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, a 24-hour urine or urine protein/creatinine ratio must be collected and must demonstrate <2 g of protein in 24 hours.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • The ability to understand and the willingness to sign a written informed consent
  • Female participants who are of non-reproductive potential (that is, post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of rivoceranib.
  • Male and female participants of reproductive potential who agree to use both a highly effective method of birth control (for example, implants, injectables, combined oral contraceptives, some intrauterine devices, complete abstinence, or sterilized partner) and a barrier method (for example condoms, cervical ring, sponge, etc.) during the period of therapy and for 30 days after the final dose of rivoceranib. Female participants should also refrain from breastfeeding and egg donation and males should refrain from sperm donation throughout this period
  • QTc interval <480 milliseconds (ms) (Common Terminology Criteria for Adverse Events [CTCAE] Grade 1) using Fredericia's QT correction formula

Who cannot join

  • Previous treatment with rivoceranib
  • Known hypersensitivity to rivoceranib or components of the formulation
  • Packed red blood cell transfusion or erythropoietin therapy within 14 days prior to the first dose of rivoceranib administration
  • History of another malignancy within 3 years prior to enrollment. A participant with the following malignancies is eligible for this study if, surgically and medically treated and in the opinion of the investigator, they do not pose a significant risk to life expectancy or not likely to recur within 3 years:
  • Carcinoma of the skin without melanomatous features
  • Curatively treated cervical carcinoma in situ
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  • Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (Tis)
  • Thyroid papillary cancer with prior treatment
  • Prostate cancer which has been surgically or medically treated
  • Prior chemotherapy, radiation therapy or major surgery within 4 weeks prior to rivoceranib administration or presence of any nonhealing wound (procedures such as catheter placement are not considered to be major surgery). Prior immunotherapy within 12 weeks prior to first dose of study drug. Palliative radiotherapy to non-target lesions within 2 weeks prior to rivoceranib administration or biopsy any time prior to rivoceranib administration is permitted.
  • Prior tyrosine kinase inhibitor therapy targeting vascular endothelial growth factor receptors (VEGFR), within 5 half-lives prior to rivoceranib administration
  • Participants who have not recovered to ≤Grade 1 from prior tyrosine kinase inhibitor-related adverse events
  • History of uncontrolled hypertension based on Investigator's clinical judgement (consistent blood pressure readings ≥140/90 millimeters of mercury [mmHg] and/or change in antihypertensive medication within 7 days prior to rivoceranib administration)
  • History of severe adverse events including uncontrolled hypertension or other common anti-angiogenesis class drug effects (for example, ramucirumab) that may indicate a higher risk to the safety of the participant if provided further anti-angiogenesis treatment, in the investigator's opinion.
  • History of vascular disease including arterial or venous embolic events (pulmonary embolism), other than hypertension, within the last 3 months prior to treatment with rivoceranib (for example, hypertensive crisis, hypertensive encephalopathy, stroke or transient ischemic attack [TIA], or significant peripheral vascular diseases) that, in the investigator's opinion, may pose a risk to the participant on vascular endothelial growth factor (VEGF) inhibitor therapy.
  • History of bleeding diathesis or clinically significant bleeding within 14 days prior to treatment with rivoceranib
  • History of clinically significant thrombosis within 3 months prior to treatment with rivoceranib that, in the investigator's opinion, may place the participant at risk of side effects from anti-angiogenesis products
  • Therapy with systemic anticoagulant or antithrombotic agents within 7 days prior to treatment with rivoceranib that in the investigator's opinion could interfere with clotting. The maximum allowable daily dose of aspirin is 325 mg.
  • Gastrointestinal malabsorption, or any other condition that in the opinion of the investigator might affect the absorption of rivoceranib
  • History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies
  • An uncontrolled intercurrent illness including, but not limited to any of the following:
  • Ongoing or active infection (including minor localized infections) requiring oral or intravenous treatment
  • Symptomatic class 3 or 4 congestive heart failure, defined as a clinical syndrome resulting from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the participant's safety or study endpoints
  • A female participant who is pregnant or breast-feeding
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • History of drug or alcohol abuse within the past 5 years
  • Known seropositive requiring anti-viral therapy for human immunodeficiency virus (HIV) infection
  • Known seropositive requiring antiviral therapy for hepatitis B virus (HBV) infection OR evidence of active hepatitis B infection by detectable viral load if the antibody tests are positive NOTE: A positive hepatitis B core antibody (HBcAb) participant with an undetectable surface antigen and negative hepatitis B deoxyribonucleic acid (DNA) test (for example, polymerase chain reaction [PCR] test) can be enrolled.
  • Known seropositive requiring antiviral therapy for hepatitis C virus (HCV) infection OR participants with positive hepatitis C virus antibody NOTE: A positive Anti-HCV participant with an undetectable/negative hepatitis C ribonucleic acid (RNA) test can be enrolled.
  • Participation in another clinical study with any investigational medication or product administered within ≤28 days prior to first dose of rivoceranib
  • Participants unable or unwilling to discontinue excluded medications for at least 5 half-lives prior to first dose of study drug

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States7 sites
  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Dana-Farber Cancer Institute - Head and Neck Oncology

    Boston, Massachusetts, 02215

  • University of Colorado Denver

    Denver, Colorado, 80204

  • University of California, Los Angeles (UCLA)

    Los Angeles, California, 90095

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • UCSF

    San Francisco, California, 94143

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

South Korea4 sites
  • National Cancer Center

    Goyang-si, Gyeonggi-do

  • Asan Medical Center

    Seoul, Gyeonggi-do

  • Seoul National University Hospital

    Seoul, Gyeonggi-do

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: 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

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.

Being tested
Rivoceranib
Medical subject headings
Carcinoma, Adenoid Cystic

What participants receive

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

  • RivoceranibDrug

    Also called Apatinib, Apatinib Mesylate

    Film-coated tablets

Study groups in NCT04119453
Study groupRoleWhat they receive
RivoceranibExperimentalParticipants will receive an oral dose of rivoceranib once per day during 28-day cycles.
Receives: Drug: Rivoceranib

What is being measured

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

  1. Objective Response Rate (ORR): Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) Per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator/Institutional Assessment

    Complete Response - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) (the sum may not be "0" if there are target nodes). Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 41 months

  2. ORR: Percentage of Participants Who Achieve Confirmed CR or PR Per RECIST 1.1 by Independent Central Review

    CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes).

    PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 41 months

Secondary outcomes (8)
  1. Overall Survival (OS) Rate

    OS was defined as the interval from the start of study therapy to death from any cause. Here, the percentage of participants with OS at specified time points are shown.

    Measured: Months 12 and 24

  2. Progression Free Survival (PFS) Rate at 6 Months, 12 Months, and 2 Years by Investigator or Institutional Assessment

    PFS was defined as the time from the start of treatment with rivoceranib to the first evaluation showing Progressive Disease (PD) or death, whichever occurred first. Participants who did not experience PD or death were censored at the date of last disease assessment. Here, the percentage of participants with PFS at the given timepoints is shown.

    PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

    Measured: Months 6, 12, and 24

  3. Progression Free Survival (PFS) at 6 Months, 12 Months, and 2 Years Evaluated by Independent Central Review

    PFS was defined as the time from the start of treatment with rivoceranib to the first evaluation showing PD or death, whichever occured first. Participants who do not experience PD or death were censored at the date of last disease assessment. Here, the percentage of participants with PFS at the given timepoints is shown.

    PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

    Measured: Months 6 and 12, and Year 2

  4. Duration of Response (DoR) Per RECIST Version 1.1 by Investigator or Institutional Assessment

    Duration of response was the time from the first response of PR or CR (which was subsequently confirmed) to the first evaluation showing PD or death, whichever occurred first. Death due to any cause was considered in the determination of DOR.

    CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes).

    PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

    Measured: Up to 41 months

  5. Duration of Response (DoR) Per RECIST Version 1.1 Evaluated by Independent Central Review

    Duration of response was the time from the first response of PR or CR (which was subsequently confirmed) to the first evaluation showing PD or death, whichever occurred first. Death due to any cause was considered in the determination of DOR.

    CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes).

    PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

    Measured: Up to 41 months

  6. Time to Progression (TTP) Per RECIST Version 1.1 by Investigator or Institutional Assessment

    TTP was the length of time from the start of treatment with rivoceranib until objective tumor progression. At the time of analysis of TTP, any participants who do not experience PD including participants who died without PD were censored at the date of last disease assessment. The TTP was estimated using the Kaplan-Meier method.

    PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

    Measured: Up to 41 months

  7. TTP Per RECIST Version 1.1 Evaluated by Independent Central Review

    TTP was the length of time from the start of treatment with rivoceranib until objective tumor progression. At the time of analysis of TTP, any participants who do not experience PD including participants who died without PD were censored at the date of last disease assessment. The TTP was estimated using the Kaplan-Meier method.

    PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

    Measured: Up to 41 months

  8. Number of Participants With Treatment-Emergent Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Measured: From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)

Timeline

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

  1. First posted8 Oct 2019
  2. Study start22 Jan 2020
  3. Primary completion28 Jun 2023
  4. Study completion28 Jun 2023

Why it stopped: The RM-202 study was terminated by the Sponsor due to redirection of the rivoceranib development plan.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04119453
Sponsor's protocol ID
RM-202
Status last verified
Jul 2026
First submitted
24 Sep 2019
Last updated
30 Jul 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivoceranib in people with Adenoid Cystic Carcinoma, run by Elevar Therapeutics at 11 sites in 2 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 22 inclusion and 34 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: stopped early, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 30 Jul 2026). 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?

Objective Response Rate (ORR): Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) Per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator/Institutional Assessment (time frame: Up to 41 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Jul 2026.

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