A Phase 2 Study of Darolutamide in Combination With Leuprolide Acetate in Hormone-Therapy Naive Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer

This phase II trial tests how well darolutamide and leuprolide acetate work in treating patients with androgen receptor positive salivary cancer that has spread from where it first started (primary site) to other places in the body (metastatic), cannot be removed by surgery (unresectable) or that has come back after a period of responding to prior therapy (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body. Giving darolutamide in combination with leuprolide acetate may help to stop the growth of tumor cells that need androgens to grow or shrink them.

开始日期2023-07-20

申办/合作机构

National Cancer Institute

NCT05694819 / Active, not recruiting临床2期IIT

Phase II Study of Darolutamide (ODM-201) in Patients With Androgen Receptor-positive Salivary Gland Carcinoma (Discovary Study)

This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen receptor-positive salivary gland carcinoma.

开始日期2020-04-17

申办/合作机构

National Cancer Center Hospital East

[+1]

NCT04325828 / Active, not recruiting临床2期

An Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Apalutamide in Combination With Gonadotropin-releasing Hormone (GnRH) Agonist in Subjects With Locally Advanced or Recurrent/Metastatic and Androgen Receptor (AR) Expressing Salivary Gland Carcinoma

The purpose of the study is to evaluate the overall response rate (ORR) of apalutamide in combination with a gonadotropin-releasing hormone (GnRH) agonist in participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC).

开始日期2020-04-07

申办/合作机构

Janssen Pharmaceuticals, Inc.

100 项与 AR阳性唾液腺肿瘤相关的临床结果

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100 项与 AR阳性唾液腺肿瘤相关的转化医学

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0 项与 AR阳性唾液腺肿瘤相关的专利（医药）

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项与 AR阳性唾液腺肿瘤相关的文献（医药）

2024-08-15·Clinical Cancer Research

Apalutamide and Goserelin for Androgen Receptor–Positive Salivary Gland Carcinoma: A Phase II Nonrandomized Clinical Trial, YATAGARASU

Article

作者: Utsumi, Yoshitaka ; Kadowaki, Shigenori ; Yamazaki, Keisuke ; Ouchi, Shohei ; Nakatogawa, Tomohiko ; Thaper, Daksh ; Takano, Ryo ; Li, Jinhui ; Aoyama, Junya ; Satake, Hironaga ; Nagao, Toshitaka ; McCarthy, Sharon ; Mundle, Suneel ; Honma, Yoshitaka ; Ogawa, Tetsuro ; Monden, Nobuya ; Brookman-May, Sabine D. ; Kano, Satoshi ; Koroki, Yosuke ; Tada, Yuichiro ; Fujii, Koji

AbstractPurpose:To assess the efficacy and safety of apalutamide plus goserelin for androgen receptor (AR)–positive unresectable or recurrent/metastatic salivary gland carcinoma.Patients and Methods:This trial was an open-label, single-arm, multicenter phase II study. Patients with histologically confirmed unresectable or recurrent/metastatic salivary gland carcinoma with AR expression were included. The primary endpoint was the overall response rate (ORR) according to RECIST v1.1 by an independent central radiology review in the first 24 response-evaluable (RE) patients who had been observed at least 24 weeks from study initiation (primary RE patients). The efficacy was to be declared when at least 8 of the 24 primary RE patients responded.Results:A total of 31 patients were enrolled. In the first 24 primary RE patients with a median follow-up of 7.4 months, confirmed ORR by independent central radiology review was 25.0% [6/24 patients; 95% confidence interval, 9.8%–46.7%; P = 0.11 (one-sided)], which did not meet the predefined criteria of efficacy. Clinical benefit rate (ORR + rate of stable disease for at least 24 weeks) and median progression-free survival were 50.0% and 7.4 months, respectively. Both median duration of response and overall survival were not reached. Exploratory analyses showed a better ORR of 54.5% (6/11) in patients with AR positivity ≥70% and no history of prior systemic therapy. Grade 3 or higher treatment-emergent adverse events were reported in 35.5% (11/31), which included skin rash, anemia, leukopenia, and cancer pain.Conclusions:Although this study did not meet the predefined efficacy criteria, apalutamide plus goserelin showed clinically meaningful efficacy in a subset of patients with AR-positive salivary gland carcinoma and safety consistent with prior experience in prostate cancer.

2023-01-01·Oral Oncology

Is it time to tailor treatments in androgen receptor positive salivary gland cancers?

Letter

作者: Cosentini, Deborah ; Bossi, Paolo ; Berruti, Alfredo ; Lorini, Luigi ; Battocchio, Simonetta ; Grisanti, Salvatore

2022-12-20·Journal of Clinical Oncology

Phase II Study of Enzalutamide for Patients With Androgen Receptor–Positive Salivary Gland Cancers (Alliance A091404)

Article

作者: Kang, Hyunseok ; Ho, Alan L. ; Morris, Luc G.T. ; Nadeem, Zaineb ; Schwartz, Gary K. ; Campbell, Jordan D. ; Foster, Nathan R. ; Munster, Pamela ; Bowles, Daniel W. ; Adkins, Douglas ; Price, Katharine ; Katabi, Nora ; Worden, Francis ; Zoroufy, Alex J. ; Morton, Roscoe ; Burtness, Barbara ; Sherman, Eric

PURPOSE The androgen receptor (AR) is expressed (+) in a subset of salivary gland cancers (SGCs). This phase II trial evaluated the efficacy of the antiandrogen enzalutamide in AR+ SGC. METHODS Patients with locally advanced/unresectable or metastatic AR+ SGCs were enrolled. Enzalutamide (160 mg) was given orally once daily. The primary end point was the best overall response rate per RECIST v1.1 within eight cycles. Confirmed responses in ≥ 5 of 41 patients would be considered promising. Secondary end points were progression-free survival, overall survival, and safety. RESULTS Forty-six patients were enrolled; 30 (65.2%) received prior systemic therapy, including 13 (28.3%) with AR-targeted drugs. Of seven (15.2%) partial responses (PRs), only two (4.3%) were confirmed per protocol and counted toward the primary end point. Twenty-four patients (52.2%) had stable disease; 15 (32.6%) had progression of disease as best response. Twenty-six patients (56.5%) experienced tumor regression in target lesions; 18 (39.1%) had partial response/stable disease ≥ 6 months. Tumor regressions were observed in female patients (5 of 6 [83.3%]) and those who received prior AR– (6 of 13 [46.2%]) or human epidermal growth factor receptor 2–targeted therapies (5 of 8 [62.5%]). Three patients remained on treatment at data cutoff (duration, 32.2-49.8 months). The median progression-free survival was 5.6 months (95% CI, 3.7 to 7.5); the median overall survival was 17.0 months (95% CI, 11.8 to 30.0). The most common adverse events were fatigue, hypertension, hot flashes, and weight loss. Total and free testosterone levels increased by a mean of 61.2% and 48.8%, respectively, after enzalutamide. CONCLUSION Enzalutamide demonstrated limited activity in AR+ SGC, failing to meet protocol-defined success in part because of a lack of response durability. Strategies to enhance the efficacy of antiandrogen therapy are needed.