bay-1000394 and Lung-Neoplasms

bay-1000394 has been researched along with Lung-Neoplasms* in 3 studies

Trials

2 trial(s) available for bay-1000394 and Lung-Neoplasms

ArticleYear
Phase II Study of Roniciclib in Combination with Cisplatin/Etoposide or Carboplatin/Etoposide as First-Line Therapy in Patients with Extensive-Disease Small Cell Lung Cancer.
    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2019, Volume: 14, Issue:4

    This phase II study evaluated the efficacy and safety of the pan-cyclin-dependent kinase inhibitor roniciclib with platinum-based chemotherapy in patients with extensive-disease SCLC.. In this randomized, double-blind study, unselected patients with previously untreated extensive-disease SCLC received roniciclib, 5 mg, or placebo twice daily according to a 3 days-on, 4 days-off schedule in 21-day cycles, with concomitant cisplatin or carboplatin on day 1 and etoposide on days 1 to 3. The primary end point was progression-free survival. Other end points included overall survival, objective response rate, and safety.. A total of 140 patients received treatment: 70 with roniciclib plus chemotherapy and 70 with placebo plus chemotherapy. Median progression-free survival times was 4.9 months (95% confidence interval [CI]: 4.2-5.5) with roniciclib plus chemotherapy and 5.5 months (95% CI: 4.6-5.6) with placebo plus chemotherapy (hazard ratio [HR] = 1.242, 95% CI: 0.820-1.881, p = 0.8653). Median overall survival times was 9.7 months (95% CI: 7.9-11.1) with roniciclib plus chemotherapy and 10.3 months (95% CI: 8.7-11.9) with placebo plus chemotherapy (HR = 1.281, 95% CI: 0.776-1.912, p = 0.7858). The objective response rates were 60.6% with roniciclib plus chemotherapy and 74.6% with placebo plus chemotherapy. Common treatment-emergent adverse events in both groups included nausea, vomiting, and fatigue. Serious treatment-emergent adverse events were more common with roniciclib plus chemotherapy (57.1%) than with placebo plus chemotherapy (38.6%).. Roniciclib combined with chemotherapy demonstrated an unfavorable risk-benefit profile in patients with extensive-disease SCLC, and the study was prematurely terminated.

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Cisplatin; Etoposide; Female; Humans; Lung Neoplasms; Male; Middle Aged; Progression-Free Survival; Pyrimidines; Small Cell Lung Carcinoma; Sulfoxides

2019
Phase I dose-escalation studies of roniciclib, a pan-cyclin-dependent kinase inhibitor, in advanced malignancies.
    British journal of cancer, 2017, Jun-06, Volume: 116, Issue:12

    To evaluate safety, pharmacokinetics, and maximum tolerated dose of roniciclib in patients with advanced malignancies, with dose expansion to evaluate clinical benefit at the recommended phase II dose (RP2D).. Two phase I dose-escalation studies evaluated two roniciclib dosing schedules: 3 days on/4 days off or 4 weeks on/2 weeks off. The expansion phase included patients with small-cell lung cancer (SCLC), ovarian cancer, or tumour mutations involving the CDK signalling pathway.. Ten patients were evaluable in the 4 weeks on/2 weeks off schedule (terminated following limited tolerability) and 47 in the 3 days on/4 days off schedule dose-escalation cohorts. On the 3 days on/4 days off schedule, RP2D was 5 mg twice daily in solid tumours (n=40); undetermined in lymphoid malignancies (n=7). Common roniciclib-related adverse events included nausea (76.6%), fatigue (65.8%), diarrhoea (63.1%), and vomiting (57.7%). Roniciclib demonstrated rapid absorption and dose-proportional increase in exposure. One partial response (1.0%) was observed. In RP2D expansion cohorts, the disease control rate (DCR) was 40.9% for patients with ovarian cancer (n=25), 17.4% for patients with SCLC (n=33), and 33.3% for patients with CDK-related tumour mutations (n=6).. Roniciclib demonstrated an acceptable safety profile and moderate DCR in 3 days on/4 days off schedule.

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Cyclin-Dependent Kinases; Diarrhea; Fatigue; Female; Gene Expression; Humans; Lung Neoplasms; Lymphoma; Male; Maximum Tolerated Dose; Middle Aged; Nausea; Neoplasms; Ovarian Neoplasms; Proliferating Cell Nuclear Antigen; Pyrimidines; Signal Transduction; Small Cell Lung Carcinoma; Sulfoxides; Vomiting

2017

Other Studies

1 other study(ies) available for bay-1000394 and Lung-Neoplasms

ArticleYear
Rethinking Our Approach of Combining Novel Agents With Standard Chemotherapy in Small Cell Lung Cancer.
    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2019, Volume: 14, Issue:4

    Topics: Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Cisplatin; Etoposide; Humans; Lung Neoplasms; Pyrimidines; Small Cell Lung Carcinoma; Sulfoxides

2019
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