A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Meta… (NCT04119453) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
Stopped: The RM-202 study was terminated by the Sponsor due to redirection of the rivoceranib development plan.
United States, South Korea80 participantsStarted 2020-01-22
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically confirmed metastatic/recurrent ACC not amenable to potentially curative surgery or radiotherapy
. Evidence of disease progression by RECIST v1.1
. 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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — can you find out why it was stopped early, and what that means for what we know about whether rivoceranib actually works for adenoid cystic carcinoma?
2Since this is a Phase 2 trial that was terminated, the safety and effectiveness data may be incomplete — are there other ongoing or completed studies of rivoceranib or similar drugs for recurrent or metastatic ACC that might give us more reliable information?
3The trial was measuring how many patients had a confirmed complete or partial tumor response — do you know if any results from this study were published or reported, and what the response rates looked like before it was stopped?
4Given that this trial is no longer recruiting, what are my actual options right now for treating recurrent or metastatic ACC — are there other clinical trials I could be considered for, or is standard treatment the stronger path for my situation?
5Are there other anti-angiogenic or tyrosine kinase inhibitors similar to rivoceranib that are being studied in ACC and might be worth discussing as alternatives?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Up to 41 months
2
ORR: Percentage of Participants Who Achieve Confirmed CR or PR Per RECIST 1.1 by Independent Central Review
. 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
. Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (Tis)