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

NCT04119453 | Terminated Phase 2 FDA Drug

• 1 other identifier: RM-202
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (2)

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

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

  Up to 48 months

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

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

  Up to 48 months

Secondary Outcomes (8)

• Overall Survival (OS) at 1 Year and 2 Years

  Years 1 and 2

• Duration of Response (DoR)

  Up to 48 months

• Duration of Response (DoR)

  Up to 48 months

• Progression free survival (PFS) at 6 Months, 12 Months, and 2 Years

  Months 6 and 12, and Year 2

• Progression free survival (PFS) at 6 Months, 12 Months, and 2 Years

  Months 6 and 12, and Year 2

Study Arms (1)

Rivoceranib

EXPERIMENTAL

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

Drug: Rivoceranib

Interventions

Rivoceranib DRUG

Film-coated tablets

Also known as: Apatinib, Apatinib Mesylate

Rivoceranib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Elevar Therapeutics: lead

Study Sites (11)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Dana-Farber Cancer Institute - Head and Neck Oncology

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, Gyeonggi-do, South Korea

Location

Seoul National University Hospital

Seoul, Gyeonggi-do, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 8, 2019
• Study Start: January 22, 2020
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

US (7); KR (4)