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 States80 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 range18 Years

SexALL

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.
✓. Adequate organ and marrow function within 14 days prior to the first dose of rivoceranib administration, defined as:
✓. Absolute neutrophil count ≥1500/microliters (μL)

Exclusion criteria

What they're measuring

Objective Response Rate (ORR): Percentage of Participants who Achieve Confirmed Complete Response (CR) or Partial Response (PR)

Timeframe: Up to 48 months

Objective Response Rate (ORR): Percentage of Participants who Achieve Confirmed Complete Response (CR) or Partial Response (PR)

Timeframe: Up to 48 months

Trial details

NCT IDNCT04119453

SponsorElevar Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-28

View on ClinicalTrials.gov More Adenoid Cystic Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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.
✓. Adequate organ and marrow function within 14 days prior to the first dose of rivoceranib administration, defined as:
✓. Absolute neutrophil count ≥1500/microliters (μL)

Exclusion criteria

What they're measuring

Objective Response Rate (ORR): Percentage of Participants who Achieve Confirmed Complete Response (CR) or Partial Response (PR)

Timeframe: Up to 48 months

Objective Response Rate (ORR): Percentage of Participants who Achieve Confirmed Complete Response (CR) or Partial Response (PR)

Timeframe: Up to 48 months