Recruiting
Phase 2
Abiraterone With Dalpiciclib in Salivary Gland Carcinoma
Condition(s) studied
Salivary Gland Carcinoma
Investigational drug(s) / intervention(s)
abiraterone combined with dalpiciclib
abiraterone combined with dalpiciclib: The dosing regimen for abiraterone combined with dalpiciclib isethionate is as follows: abiraterone is administered orally at 1 g once daily, in combination with prednisone 5 mg orally twice daily.
The recommended dose of dalpiciclib isethionate is 150 mg once daily for 21 consecutive days, followed by a 7-day treatment break (3-on/1-off schedule), constituting a 28-day treatment cycle. Study subjects should take the medication at approximately the same time each day.
Subjects will continue abiraterone plus dalpiciclib isethionate treatment until discontinuation criteria are met.
Study summary
This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of abiraterone combined with dalpiciclib in recurrent/metastatic salivary gland carcinoma patients with AR positive and Her-2 negative. The participants would receive abiraterone combined with dalpiciclib until termination criteria are met.
Eligibility
Inclusion Criteria:
* \- Aged 18-75 years, male or female;
* Patients with histopathologically confirmed salivary gland malignancy of the head and neck: recurrent/metastatic disease without curative-intent therapeutic options (surgery/radiotherapy), or unresectable locally-advanced disease, with at least one measurable lesion (≥10 mm on spiral CT, complying with RECIST version 1.1);
* HER-2-negative and AR-positive status determined by immunohistochemistry (IHC);
* Availability of evaluable tumor tissue (paraffin-embedded specimen obtained within the past 2 years or fresh tumor tissue);
* ECOG performance status of 0 or 1;
* Expected survival ≥12 weeks;
* Adequate major-organ function within 2 weeks prior to study treatment initiation, meeting the following criteria:
* Bone marrow: haemoglobin ≥100 g/L, white blood cell count ≥4.0 × 10⁹/L or absolute neutrophil count ≥2.0 × 10⁹/L, platelet count ≥100 × 10⁹/L, in the absence of transfusion or colony-stimulating factor support;
* Liver: total serum bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN;
* Kidney: serum creatinine ≤1.5 × ULN OR creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L;
* Urine protein: negative; if urine protein is 1+, 24-hour total urinary protein must be \<500 mg;
* Glucose: within normal range; or patients with diabetes with stable glycaemic control under ongoing management;
* Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency;
* For women of child-bearing potential: negative serum pregnancy test within 7 days before the first dose of study drug. Men with reproductive potential and women at risk of pregnancy must use highly-effective contraceptive measures throughout the study (e.g., oral contraceptives, intrauterine device, sexual abstinence, or barrier contraception combined with spermicide), and continue contraception for 12 months after treatment completion;
* Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and are willing to complete follow-up assessments;
* Patients for whom the investigator judges treatment may confer clinical benefit.
Exclusion Criteria:
* \- Patients with prior exposure to anti-androgen therapy or CDK4/6 inhibitors.
* Patients receiving ongoing anti-neoplastic treatment.
* Patients who have participated in, or are participating in, another investigational drug/therapy clinical trial within 4 weeks prior to the first dose of study drug.
* Patients who received haematopoietic stimulating factors, such as granulocyte-colony-stimulating factor (G-CSF) or erythropoietin, within 1 week before the first administration of study drug.
* Positive serology for human immunodeficiency virus (HIV) antibody or \*Treponema pallidum\* antibody.
* Patients with active hepatitis B or hepatitis C:
* HBsAg-positive or HBcAb-positive subjects with detectable HBV DNA (value above the upper limit of normal);
* Subjects with positive HCV antibody and detectable HCV RNA (value above the upper limit of normal).
* Symptomatic and clinically significant pleural effusion or ascites requiring therapeutic intervention.
* Active pulmonary disease (interstitial pneumonia, pneumonitis, obstructive pulmonary disease, asthma) or history of active pulmonary tuberculosis.
* Presence of any uncontrolled clinical conditions, including but not limited to:
* Persistent or active (severe) infection;
* Poorly-controlled diabetes mellitus;
* Cardiac disease (New York Heart Association (NYHA) class III/IV congestive heart failure or cardiac conduction block).
* Occurrence of any of the following events within 6 months prior to first-dose administration: deep-vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischaemic attack, cerebral embolism.
* Prior history of stem-cell transplantation or solid-organ transplantation.
* History of substance abuse of psychotropic agents without successful abstinence, or history of psychiatric disorders.
* Other severe, acute or chronic medical conditions or laboratory abnormalities which, in the investigator's judgement, may increase risks associated with study participation or confound the interpretation of study results.
* Patients deemed by the investigator to have poor compliance, or with other conditions rendering them unsuitable for trial participation.
* Patients with a history of another malignancy within the past five years.
Primary outcome measure(s)
- objective response rate — 12 months
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Trial sites (1)
| Facility | City | Region | Status |
| the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine |
Shanghai |
Shanghai Municipality |
Recruiting |
More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China
Other trials for the same condition