Phase Ib Trial of Cabazitaxel and Tasquinimod in Men With Heavily Pretreated Metastatic Castration Resistant Prostate Cancer (mCRPC): The CATCH Trial

Armstrong, Andrew J.; Humeniuk, Michael S.; Healy, Patrick; Szmulewitz, Russell Z.; Winters, Carolyn; Kephart, Julie J.G.; Harrison, Michael R.; Martinez, Elia; Mundy, Kelly; Halabi, Susan; George, Daniel J.

doi:10.1002/pros.23277

Cited by 8 publications

(12 citation statements)

References 22 publications

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“…Cabazitaxel is also being studied with a small-molecule inhibitor tasquinimod in the Phase I CATCH trial. 27 Tasquinimod limits the activity of myeloid-derived suppressor cells (MDSCs), which accumulate in the tumor microenvironment and inhibit the antitumor activity of T, natural killer, and dendritic cells. The small molecule binds to protein S100A8/A9 and interrupts the positive feedback of further MDSC recruitment.…”

Section: Treatment Sequencingmentioning

confidence: 99%

Cabazitaxel in the treatment of metastatic castration-resistant prostate cancer: patient selection and special considerations

Patel

Hoffman-Censits

2017

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Cabazitaxel is an effective chemotherapeutic agent used in the treatment of metastatic castration-resistant prostate cancer (mCRPC) refractory to docetaxel. With the advent of new antiandrogen therapies, immune-based treatments, and radioactive-targeted therapy, there are now multiple effective and approved agents for this disease state. The optimal sequencing of these agents is unclear as there are no large-scale head-to-head comparisons. Clinicians must familiarize themselves with the most recent studies as well as drug toxicities to determine the best treatment option for their patients. In this review, we focus on the development of cabazitaxel for mCRPC, evaluate its efficacy, and highlight key strategies for toxicity management. Additionally, we summarize the studies that address cabazitaxel treatment sequencing and optimal dosing schedule.

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Section: Treatment Sequencingmentioning

confidence: 99%

Cabazitaxel in the treatment of metastatic castration-resistant prostate cancer: patient selection and special considerations

Patel

Hoffman-Censits

2017

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“… 25 The results from this study have provided a rationale for clinical testing of a tasquinimod combination with chemotherapy in CRPC patients. As cabazitaxel in combination with prednisone has emerged as a standard chemotherapy in the post-docetaxel setting, 53 , 54 the CATCH prostate cancer trial (NCT01513733) 55 has been initiated where a combination of tasquinimod and cabazitaxel is being tested in metastatic CRPC after progression on docetaxel (see below).…”

Section: Combination Strategies With Tasquinimod In Crpcmentioning

confidence: 99%

“… 56 By combining the results of these studies showing improved antitumor response in prostate cancer with combination of tasquinimod and androgen ablation or radiation therapy, it is conceivable that these combinations may be a successful therapeutic approach which warrants further testing. 25 , 55 …”

Section: Combination Strategies With Tasquinimod In Crpcmentioning

confidence: 99%

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Mechanism of action and clinical activity of tasquinimod in castrate-resistant prostate cancer

Gupta¹,

Ustwani²,

Шен³

et al. 2014

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Castrate-resistant prostate cancer (CRPC) is a disease where survival is poor and treatment is challenging. Over the past 3 years, significant advances in the field have been made with US Food and Drug Administration approval of new drugs for patients with CRPC. However, despite the presence of new approved drugs such as enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and alpharadin, there is still an unmet need for novel agents with different mechanisms of action to target CRPC. Based on earlier studies demonstrating therapeutic potential of a quinoline-3-carboxamide agent roquinimex as an anticancer drug, efforts were directed to identify other useful members in this class. Tasquinimod is a second-generation quinoline-3-carboxamide agent that is currently in final stages of clinical development as a treatment for CRPC. The preclinical studies of tasquinimod have formed the basis for its success as an antiangiogenic and immunomodulatory agent in this disease. Tasquinimod is an orally available agent that has shown efficacy and favorable safety profile as deduced by the results of Phase I and II clinical trials of this drug in prostate cancer. The place of tasquinimod in the treatment of CRPC patients is currently under examination in an ongoing Phase III clinical trial. In this review, we will discuss tasquinimod, starting from its discovery and current knowledge on potential mechanisms of action to its clinical potential in CRPC.

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“…The phase Ib trial CATCH (NCT01513733) assessed the safety and activity of tasquinimod plus cabazitaxel versus cabazitaxel monotherapy in 25 patients with pretreated Completed phase III clinical trials with immunotherapeutic treatments for genitourinary malignancies Petrylak et al [155] Lenalidomide + docetaxel + prednisone vs. docetaxel + prednisone mCRPC (first-line) mCRPC, metastatic castration-resistant prostate cancer; mRCC, metastatic renal cell carcinoma; OS, overall survival; RT, radiotherapy.mCRPC[161]. The preliminary results of this study indicated a more than 30% PSA decrease in 63% of patients (95% CI: 41-81) and a median composite PFS of 8.5 months (95% CI: 4.2-16.4).…”

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confidence: 99%

Immunotherapy for genitourinary cancer

et al. 2016

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In the last few years, cancer immunotherapy has changed the natural history and treatment strategies of a number of solid tumors, including melanoma and lung cancer. The anti-PD-1 nivolumab showed a survival benefit compared with everolimus in the second-line treatment of renal cell carcinoma, resulting in a radical shift in perspective in the treatment of this neoplasia and suggesting a new scenario beyond tyrosine kinase inhibitors. Checkpoint inhibitors might also improve the treatment of urothelial cancer, considering the promising results achieved so far and the relatively low efficacy of currently available treatments. Sipuleucel-T was the first approved immunotherapy for prostate cancer, showing a clear benefit in overall survival, and paved the way for the clinical testing of other novel cancer vaccines. This review provides a comprehensive overview of the current knowledge and new perspectives of immunotherapy in the treatment of urogenital malignancies.

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Phase Ib Trial of Cabazitaxel and Tasquinimod in Men With Heavily Pretreated Metastatic Castration Resistant Prostate Cancer (mCRPC): The CATCH Trial

Abstract: We determined the RP2D of tasquinimod combined with cabazitaxel to be 0.5 mg daily following a 3 week lead-in of tasquinimod 0.25 mg with growth factor support. No unexpected toxicities occurred. Prostate 77: 385-395, 2017. © 2016 Wiley Periodicals, Inc.

Cited by 8 publications

References 22 publications

Cabazitaxel in the treatment of metastatic castration-resistant prostate cancer: patient selection and special considerations

Cabazitaxel in the treatment of metastatic castration-resistant prostate cancer: patient selection and special considerations

Mechanism of action and clinical activity of tasquinimod in castrate-resistant prostate cancer

Immunotherapy for genitourinary cancer

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