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
This is a Phase 2, multicenter, open-label, single-arm study of rivoceranib to evaluate its efficacy and safety in adult subjects with metastatic ACC of all anatomic sites of origin.
Primary Objective: To evaluate the efficacy of rivoceranib in subjects with recurrent or metastatic adenoid cystic adenocarcinoma (ACC) based on
assessment of objective response rate (ORR). Secondary Objective: To further evaluate the efficacy in subjects with recurrent or metastatic ACC: Overall survival (OS), Disease control rate (DCR), Progression free survival (PFS) and Time to progression (TTP). To evaluate the safety of rivoceranib. Exploratory Objectives: To explore pharmacodynamics markers, to evaluate the pharmacokinetics (PK) of revoceranib. To evaluate quality of life measurements during treatment with rivoceranib.
Histologically or cytologically confirmed metastatic/recurrent Adenoid Cystic Carcinoma (ACC) not amenable to potentially curative surgery or radiotherapy
Evidence of disease progression as defined per protocol
Presence of at least one measurable target lesion which is evaluable by RECIST Version 1.1 criteria
Patients are eligible if CNS metastases have been treated and patients are neurologically retunred 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, patients must be either off corticosteroids, or on a stable dose or decreasing dose of > Adequate organ and marrow function within 14 days prior to the first dose of rivoceranib administration, as defined per protocol.
Men and women 18 years of age or older
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 patients who are of non-reproductive potential (i.e. post-menopausal by history – no menses for at least 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of rivoceranib
Male and female patients of reproductive potential who agree to use both a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices, complete abstinence, or sterilized partner) and a barrier method (e.g. condoms, cervical ring, sponge, etc.) during the period of therapy and for 30 days after the final dose of rivoceranib. Females should also refrain from breastfeeding and egg donation and males should refrain from sperm donation throughout this period
QTc interval less than 480 milliseconds (ms) (CTCAE Grade 1) using Fredericia’s QT correction formula.
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 patient 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: (a)Carcinoma of the skin without melanomatous features (b) Curatively treated cervical carcinoma in situ (c) Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (d) Thyroid papillary cancer with prior treatment (e) 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 VEGFR, within 5 half-lives prior to rivoceranib administration
Patients who have not recovered to ≤ Grade 1 from prior tyrosine kinase inhibitor-related adverse events
History of uncontrolled hypertension (blood pressure ≥140/90 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 (e.g. ramucirumab) that may indicate a higher risk to the safety of the patient 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 (e.g. 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 patient on 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 patient 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
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