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Efficacy and safety of S-1 following gemcitabine with cisplatin for advanced biliary tract cancer.

Investigational new drugs

Inoue H, Todaka A, Yamazaki K, Fushiki K, Shirasu H, Kawakami T, Tsushima T, Hamauchi S, Yokota T, Machida N, Fukutomi A, Onozawa Y, Andoh A, Yasui H.
PMID: 33835357
Invest New Drugs. 2021 Oct;39(5):1399-1404. doi: 10.1007/s10637-021-01098-2. Epub 2021 Apr 09.

Background Combination therapy of gemcitabine with cisplatin (GC) is a standard first-line therapy for unresectable or recurrent biliary tract cancer (BTC). S-1 is often used as a second-line therapy in clinical practice, based on the results of some clinical...

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Inoue H, Todaka A, Yamazaki K, et al. Efficacy and safety of S-1 following gemcitabine with cisplatin for advanced biliary tract cancer. Invest New Drugs. 2021;39(5):1399-1404doi: 10.1007/s10637-021-01098-2.
Inoue, H., Todaka, A., Yamazaki, K., Fushiki, K., Shirasu, H., Kawakami, T., Tsushima, T., Hamauchi, S., Yokota, T., Machida, N., Fukutomi, A., Onozawa, Y., Andoh, A., & Yasui, H. (2021). Efficacy and safety of S-1 following gemcitabine with cisplatin for advanced biliary tract cancer. Investigational new drugs, 39(5), 1399-1404. https://doi.org/10.1007/s10637-021-01098-2
Inoue, Hiroto, et al. "Efficacy and safety of S-1 following gemcitabine with cisplatin for advanced biliary tract cancer." Investigational new drugs vol. 39,5 (2021): 1399-1404. doi: https://doi.org/10.1007/s10637-021-01098-2
Inoue H, Todaka A, Yamazaki K, Fushiki K, Shirasu H, Kawakami T, Tsushima T, Hamauchi S, Yokota T, Machida N, Fukutomi A, Onozawa Y, Andoh A, Yasui H. Efficacy and safety of S-1 following gemcitabine with cisplatin for advanced biliary tract cancer. Invest New Drugs. 2021 Oct;39(5):1399-1404. doi: 10.1007/s10637-021-01098-2. Epub 2021 Apr 09. PMID: 33835357; PMCID: PMC8426227.
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A multicenter phase 1/2 study investigating the safety, pharmacokinetics, pharmacodynamics and efficacy of a small molecule antimetabolite, RX-3117, plus nab-paclitaxel in pancreatic adenocarcinoma.

Investigational new drugs

Babiker H, Schlegel PJ, Hicks LG, Bullock AJ, Burhani N, Mahadevan D, Elquza E, Borad MJ, Benaim E, Peterson C, Heaton C, Ocean AJ.
PMID: 34417914
Invest New Drugs. 2021 Aug 21; doi: 10.1007/s10637-021-01164-9. Epub 2021 Aug 21.

Background RX-3117 is an oral small molecule antimetabolite, cyclopentyl pyrimidyl nucleoside that is activated by cancer cells over-expressing uridine cytidine kinase 2 (UCK2). Single agent RX-3117 demonstrated efficacy in a phase I trial in patients with metastatic (met) pancreatic...

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Babiker H, Schlegel PJ, Hicks LG, et al. A multicenter phase 1/2 study investigating the safety, pharmacokinetics, pharmacodynamics and efficacy of a small molecule antimetabolite, RX-3117, plus nab-paclitaxel in pancreatic adenocarcinoma. Invest New Drugs. 2021;doi: 10.1007/s10637-021-01164-9.
Babiker, H., Schlegel, P. J., Hicks, L. G., Bullock, A. J., Burhani, N., Mahadevan, D., Elquza, E., Borad, M. J., Benaim, E., Peterson, C., Heaton, C., & Ocean, A. J. (2021). A multicenter phase 1/2 study investigating the safety, pharmacokinetics, pharmacodynamics and efficacy of a small molecule antimetabolite, RX-3117, plus nab-paclitaxel in pancreatic adenocarcinoma. Investigational new drugs, . https://doi.org/10.1007/s10637-021-01164-9
Babiker, Hani, et al. "A multicenter phase 1/2 study investigating the safety, pharmacokinetics, pharmacodynamics and efficacy of a small molecule antimetabolite, RX-3117, plus nab-paclitaxel in pancreatic adenocarcinoma." Investigational new drugs vol. (2021). doi: https://doi.org/10.1007/s10637-021-01164-9
Babiker H, Schlegel PJ, Hicks LG, Bullock AJ, Burhani N, Mahadevan D, Elquza E, Borad MJ, Benaim E, Peterson C, Heaton C, Ocean AJ. A multicenter phase 1/2 study investigating the safety, pharmacokinetics, pharmacodynamics and efficacy of a small molecule antimetabolite, RX-3117, plus nab-paclitaxel in pancreatic adenocarcinoma. Invest New Drugs. 2021 Aug 21; doi: 10.1007/s10637-021-01164-9. Epub 2021 Aug 21. PMID: 34417914.
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Correction to: Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma.

Investigational new drugs

Weiss GJ, Blaydorn L, Beck J, Bornemann-Kolatzki K, Urnovitz H, Schütz E, Khemka V.
PMID: 31020607
Invest New Drugs. 2019 Aug;37(4):797. doi: 10.1007/s10637-019-00763-x.

The authors would like to note an error in Figures 1 and 2 of this paper. The graph in Figure 1 incorrectly reflected the overall survival (OS), when it should have displayed the progression-free survival (PFS). The caption and...

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Weiss GJ, Blaydorn L, Beck J, et al. Correction to: Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma. Invest New Drugs. 2019;37(4):797doi: 10.1007/s10637-019-00763-x.
Weiss, G. J., Blaydorn, L., Beck, J., Bornemann-Kolatzki, K., Urnovitz, H., Schütz, E., & Khemka, V. (2019). Correction to: Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma. Investigational new drugs, 37(4), 797. https://doi.org/10.1007/s10637-019-00763-x
Weiss, Glen J, et al. "Correction to: Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma." Investigational new drugs vol. 37,4 (2019): 797. doi: https://doi.org/10.1007/s10637-019-00763-x
Weiss GJ, Blaydorn L, Beck J, Bornemann-Kolatzki K, Urnovitz H, Schütz E, Khemka V. Correction to: Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma. Invest New Drugs. 2019 Aug;37(4):797. doi: 10.1007/s10637-019-00763-x. PMID: 31020607.
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Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell carcinoma: a prospective, single-arm, open-label, phase II study.

Investigational new drugs

Wang ZQ, Wang DS, Wang FH, Ren C, Tan Q, Li YH.
PMID: 33070249
Invest New Drugs. 2021 Apr;39(2):516-523. doi: 10.1007/s10637-020-01021-1. Epub 2020 Oct 18.

Background The prognosis of esophageal squamous cell carcinoma (ESCC) are still poor. Nedaplatin/paclitaxel regimen has shown activity with lower toxicity in metastatic ESCC. Recombinant human endostatin (Rh-endostatin), an inhibitor of angiogenesis, has shown inhibitory effects on ESCC xenograft. We...

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Wang ZQ, Wang DS, Wang FH, et al. Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell carcinoma: a prospective, single-arm, open-label, phase II study. Invest New Drugs. 2020;39(2):516-523doi: 10.1007/s10637-020-01021-1.
Wang, Z. Q., Wang, D. S., Wang, F. H., Ren, C., Tan, Q., & Li, Y. H. (2021). Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell carcinoma: a prospective, single-arm, open-label, phase II study. Investigational new drugs, 39(2), 516-523. https://doi.org/10.1007/s10637-020-01021-1
Wang, Zhi-Qiang, et al. "Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell carcinoma: a prospective, single-arm, open-label, phase II study." Investigational new drugs vol. 39,2 (2021): 516-523. doi: https://doi.org/10.1007/s10637-020-01021-1
Wang ZQ, Wang DS, Wang FH, Ren C, Tan Q, Li YH. Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell carcinoma: a prospective, single-arm, open-label, phase II study. Invest New Drugs. 2021 Apr;39(2):516-523. doi: 10.1007/s10637-020-01021-1. Epub 2020 Oct 18. PMID: 33070249.
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Preliminary evaluation of anticancer efficacy of pioglitazone combined with celecoxib for the treatment of non-small cell lung cancer.

Investigational new drugs

Kiran AVVVR, Kumari GK, Krishnamurthy PT.
PMID: 34341904
Invest New Drugs. 2022 Feb;40(1):1-9. doi: 10.1007/s10637-021-01158-7. Epub 2021 Aug 02.

PURPOSE: Among the lung cancer types, non-small cell lung cancer (NSCLC) is prominent and less responsive to chemotherapy. The current chemotherapeutics for NSCLC are associated with several dose-limiting side effects like bone-marrow suppression, neurotoxicity, nephrotoxicity, and ototoxicity, etc. which...

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Kiran AVVVR, Kumari GK, Krishnamurthy PT. Preliminary evaluation of anticancer efficacy of pioglitazone combined with celecoxib for the treatment of non-small cell lung cancer. Invest New Drugs. 2021;40(1):1-9doi: 10.1007/s10637-021-01158-7.
Kiran, A. V. V. V. R., Kumari, G. K., & Krishnamurthy, P. T. (2022). Preliminary evaluation of anticancer efficacy of pioglitazone combined with celecoxib for the treatment of non-small cell lung cancer. Investigational new drugs, 40(1), 1-9. https://doi.org/10.1007/s10637-021-01158-7
Kiran, Ammu V V V Ravi, et al. "Preliminary evaluation of anticancer efficacy of pioglitazone combined with celecoxib for the treatment of non-small cell lung cancer." Investigational new drugs vol. 40,1 (2022): 1-9. doi: https://doi.org/10.1007/s10637-021-01158-7
Kiran AVVVR, Kumari GK, Krishnamurthy PT. Preliminary evaluation of anticancer efficacy of pioglitazone combined with celecoxib for the treatment of non-small cell lung cancer. Invest New Drugs. 2022 Feb;40(1):1-9. doi: 10.1007/s10637-021-01158-7. Epub 2021 Aug 02. PMID: 34341904.
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Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen.

Investigational new drugs

Isomoto K, Haratani K, Watanabe S, Takeda M, Iwasa T, Nakagawa K.
PMID: 34463889
Invest New Drugs. 2022 Feb;40(1):194-197. doi: 10.1007/s10637-021-01168-5. Epub 2021 Aug 31.

Extramammary Paget disease (EMPD) is a rare cutaneous adenocarcinoma that usually is of epidermal origin and shows glandular differentiation and that is treated by wide local excision depending on the disease extent. For widely metastatic disease, however, a standard...

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Isomoto K, Haratani K, Watanabe S, et al. Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen. Invest New Drugs. 2021;40(1):194-197doi: 10.1007/s10637-021-01168-5.
Isomoto, K., Haratani, K., Watanabe, S., Takeda, M., Iwasa, T., & Nakagawa, K. (2022). Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen. Investigational new drugs, 40(1), 194-197. https://doi.org/10.1007/s10637-021-01168-5
Isomoto, Kohsuke, et al. "Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen." Investigational new drugs vol. 40,1 (2022): 194-197. doi: https://doi.org/10.1007/s10637-021-01168-5
Isomoto K, Haratani K, Watanabe S, Takeda M, Iwasa T, Nakagawa K. Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen. Invest New Drugs. 2022 Feb;40(1):194-197. doi: 10.1007/s10637-021-01168-5. Epub 2021 Aug 31. PMID: 34463889.
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Improved pharmacokinetic and pharmacodynamic profile of a novel PEGylated native Erwinia chrysanthemi L-Asparaginase.

Investigational new drugs

Modi T, Gervais D.
PMID: 34468906
Invest New Drugs. 2022 Feb;40(1):21-29. doi: 10.1007/s10637-021-01173-8. Epub 2021 Sep 01.

INTRODUCTION:  Erwinase® (native Erwinia chrysanthemi L-Asparaginase (nErA)) is an approved second-line treatment for acute lymphoblastic leukaemia (ALL) in children and adolescents, who develop hypersensitivity or neutralising antibodies to E.coli derived L-Asparaginases (ASNases). However, nErA has a short in vivo...

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Modi T, Gervais D. Improved pharmacokinetic and pharmacodynamic profile of a novel PEGylated native Erwinia chrysanthemi L-Asparaginase. Invest New Drugs. 2021;40(1):21-29doi: 10.1007/s10637-021-01173-8.
Modi, T., & Gervais, D. (2022). Improved pharmacokinetic and pharmacodynamic profile of a novel PEGylated native Erwinia chrysanthemi L-Asparaginase. Investigational new drugs, 40(1), 21-29. https://doi.org/10.1007/s10637-021-01173-8
Modi, Tapasvi, and Gervais, David. "Improved pharmacokinetic and pharmacodynamic profile of a novel PEGylated native Erwinia chrysanthemi L-Asparaginase." Investigational new drugs vol. 40,1 (2022): 21-29. doi: https://doi.org/10.1007/s10637-021-01173-8
Modi T, Gervais D. Improved pharmacokinetic and pharmacodynamic profile of a novel PEGylated native Erwinia chrysanthemi L-Asparaginase. Invest New Drugs. 2022 Feb;40(1):21-29. doi: 10.1007/s10637-021-01173-8. Epub 2021 Sep 01. PMID: 34468906.
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Signal transducer and activator of transcription 3 inhibition alleviates resistance to BRAF inhibition in anaplastic thyroid cancer.

Investigational new drugs

Wang Y, Hu Z, Ma W, Niu Y, Su J, Zhang L, Zhao P.
PMID: 33245464
Invest New Drugs. 2021 Jun;39(3):764-774. doi: 10.1007/s10637-020-01024-y. Epub 2020 Nov 27.

Anaplastic thyroid cancer (ATC) is a rare type of thyroid cancer (TC) with no effective therapeutic strategy. Although surgery, chemotherapy and radiation are all available for ATC treatment, the median survival for ATC patients is less than 6 months....

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Wang Y, Hu Z, Ma W, et al. Signal transducer and activator of transcription 3 inhibition alleviates resistance to BRAF inhibition in anaplastic thyroid cancer. Invest New Drugs. 2020;39(3):764-774doi: 10.1007/s10637-020-01024-y.
Wang, Y., Hu, Z., Ma, W., Niu, Y., Su, J., Zhang, L., & Zhao, P. (2021). Signal transducer and activator of transcription 3 inhibition alleviates resistance to BRAF inhibition in anaplastic thyroid cancer. Investigational new drugs, 39(3), 764-774. https://doi.org/10.1007/s10637-020-01024-y
Wang, Ying, et al. "Signal transducer and activator of transcription 3 inhibition alleviates resistance to BRAF inhibition in anaplastic thyroid cancer." Investigational new drugs vol. 39,3 (2021): 764-774. doi: https://doi.org/10.1007/s10637-020-01024-y
Wang Y, Hu Z, Ma W, Niu Y, Su J, Zhang L, Zhao P. Signal transducer and activator of transcription 3 inhibition alleviates resistance to BRAF inhibition in anaplastic thyroid cancer. Invest New Drugs. 2021 Jun;39(3):764-774. doi: 10.1007/s10637-020-01024-y. Epub 2020 Nov 27. PMID: 33245464.
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Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen.

Investigational new drugs

Isomoto K, Haratani K, Watanabe S, Takeda M, Iwasa T, Nakagawa K.
PMID: 34463889
Invest New Drugs. 2021 Aug 31; doi: 10.1007/s10637-021-01168-5. Epub 2021 Aug 31.

Extramammary Paget disease (EMPD) is a rare cutaneous adenocarcinoma that usually is of epidermal origin and shows glandular differentiation and that is treated by wide local excision depending on the disease extent. For widely metastatic disease, however, a standard...

Cite
Isomoto K, Haratani K, Watanabe S, et al. Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen. Invest New Drugs. 2021;doi: 10.1007/s10637-021-01168-5.
Isomoto, K., Haratani, K., Watanabe, S., Takeda, M., Iwasa, T., & Nakagawa, K. (2021). Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen. Investigational new drugs, . https://doi.org/10.1007/s10637-021-01168-5
Isomoto, Kohsuke, et al. "Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen." Investigational new drugs vol. (2021). doi: https://doi.org/10.1007/s10637-021-01168-5
Isomoto K, Haratani K, Watanabe S, Takeda M, Iwasa T, Nakagawa K. Successful treatment of a case of hormone receptor-positive metastatic extramammary Paget disease with tamoxifen. Invest New Drugs. 2021 Aug 31; doi: 10.1007/s10637-021-01168-5. Epub 2021 Aug 31. PMID: 34463889.
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Phase I study of weekly nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer.

Investigational new drugs

Omori S, Harada H, Mori K, Hisamatsu Y, Tsuboguchi Y, Yoshioka H, Morinaga R, Daga H, Kurata T, Takahashi T.
PMID: 34495421
Invest New Drugs. 2022 Feb;40(1):106-114. doi: 10.1007/s10637-021-01155-w. Epub 2021 Sep 08.

Few clinical studies have been designed for elderly patients with locally advanced non-small cell lung cancer (NSCLC). We conducted a phase I study to evaluate the tolerability of carboplatin/nab-paclitaxel and concurrent thoracic radiotherapy in elderly patients with locally advanced...

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Omori S, Harada H, Mori K, et al. Phase I study of weekly nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer. Invest New Drugs. 2021;40(1):106-114doi: 10.1007/s10637-021-01155-w.
Omori, S., Harada, H., Mori, K., Hisamatsu, Y., Tsuboguchi, Y., Yoshioka, H., Morinaga, R., Daga, H., Kurata, T., & Takahashi, T. (2022). Phase I study of weekly nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer. Investigational new drugs, 40(1), 106-114. https://doi.org/10.1007/s10637-021-01155-w
Omori, Shota, et al. "Phase I study of weekly nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer." Investigational new drugs vol. 40,1 (2022): 106-114. doi: https://doi.org/10.1007/s10637-021-01155-w
Omori S, Harada H, Mori K, Hisamatsu Y, Tsuboguchi Y, Yoshioka H, Morinaga R, Daga H, Kurata T, Takahashi T. Phase I study of weekly nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer. Invest New Drugs. 2022 Feb;40(1):106-114. doi: 10.1007/s10637-021-01155-w. Epub 2021 Sep 08. PMID: 34495421.
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Successful treatment of an osimertinib-resistant lung adenocarcinoma with an exon 18 EGFR mutation (G719S) with afatinib plus bevacizumab.

Investigational new drugs

Tamiya M, Kunimasa K, Nishino K, Matsumoto S, Kawachi H, Kuno K, Inoue T, Kuhara H, Imamura F, Goto K, Kumagai T.
PMID: 32556898
Invest New Drugs. 2021 Feb;39(1):232-236. doi: 10.1007/s10637-020-00966-7. Epub 2020 Jun 18.

Exon 18 mutations account for only 3.6% of EGFR mutations, and tumors with exon 18 mutations are often unresponsive to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). We present a novel case of a lung adenocarcinoma with...

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Tamiya M, Kunimasa K, Nishino K, et al. Successful treatment of an osimertinib-resistant lung adenocarcinoma with an exon 18 EGFR mutation (G719S) with afatinib plus bevacizumab. Invest New Drugs. 2020;39(1):232-236doi: 10.1007/s10637-020-00966-7.
Tamiya, M., Kunimasa, K., Nishino, K., Matsumoto, S., Kawachi, H., Kuno, K., Inoue, T., Kuhara, H., Imamura, F., Goto, K., & Kumagai, T. (2021). Successful treatment of an osimertinib-resistant lung adenocarcinoma with an exon 18 EGFR mutation (G719S) with afatinib plus bevacizumab. Investigational new drugs, 39(1), 232-236. https://doi.org/10.1007/s10637-020-00966-7
Tamiya, Motohiro, et al. "Successful treatment of an osimertinib-resistant lung adenocarcinoma with an exon 18 EGFR mutation (G719S) with afatinib plus bevacizumab." Investigational new drugs vol. 39,1 (2021): 232-236. doi: https://doi.org/10.1007/s10637-020-00966-7
Tamiya M, Kunimasa K, Nishino K, Matsumoto S, Kawachi H, Kuno K, Inoue T, Kuhara H, Imamura F, Goto K, Kumagai T. Successful treatment of an osimertinib-resistant lung adenocarcinoma with an exon 18 EGFR mutation (G719S) with afatinib plus bevacizumab. Invest New Drugs. 2021 Feb;39(1):232-236. doi: 10.1007/s10637-020-00966-7. Epub 2020 Jun 18. PMID: 32556898.
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Correction to: Germinal Immunogenetics predict treatment outcome for PD-1/PD-L1 checkpoint inhibitors.

Investigational new drugs

Refae S, Gal J, Ebran N, Otto J, Borchiellini D, Peyrade F, Chamorey E, Brest P, Milano G, Saada-Bouzid E.
PMID: 32500464
Invest New Drugs. 2021 Feb;39(1):287-292. doi: 10.1007/s10637-020-00954-x.

No abstract available.

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Refae S, Gal J, Ebran N, et al. Correction to: Germinal Immunogenetics predict treatment outcome for PD-1/PD-L1 checkpoint inhibitors. Invest New Drugs. 2021;39(1):287-292doi: 10.1007/s10637-020-00954-x.
Refae, S., Gal, J., Ebran, N., Otto, J., Borchiellini, D., Peyrade, F., Chamorey, E., Brest, P., Milano, G., & Saada-Bouzid, E. (2021). Correction to: Germinal Immunogenetics predict treatment outcome for PD-1/PD-L1 checkpoint inhibitors. Investigational new drugs, 39(1), 287-292. https://doi.org/10.1007/s10637-020-00954-x
Refae, Sadal, et al. "Correction to: Germinal Immunogenetics predict treatment outcome for PD-1/PD-L1 checkpoint inhibitors." Investigational new drugs vol. 39,1 (2021): 287-292. doi: https://doi.org/10.1007/s10637-020-00954-x
Refae S, Gal J, Ebran N, Otto J, Borchiellini D, Peyrade F, Chamorey E, Brest P, Milano G, Saada-Bouzid E. Correction to: Germinal Immunogenetics predict treatment outcome for PD-1/PD-L1 checkpoint inhibitors. Invest New Drugs. 2021 Feb;39(1):287-292. doi: 10.1007/s10637-020-00954-x. PMID: 32500464.
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