Table 2. Clinical trials of volasertib in solid and hematologic malignancies.
| Description | Treatment | Dose | Indication | Number of patients | Reference |
|---|---|---|---|---|---|
| Trials in solid tumors | |||||
| Phase I, dose escalation (NCT00969553) | Volasertib | 12–450 mg | Advanced solid tumors | 65 | Schöffski et al.26 |
| Phase I, dose escalation in Japanese patients (NCT01348347) | Volasertib | Schedule A (q3w): 100–300 mg; schedule B (q2w): 50–200 mg | Advanced solid tumors | 52 | Lin et al.35 |
| Phase II, single arm, open label (NCT01023958) | Volasertib | 300–350 mg | Locally advanced or metastatic urothelial cancer | 50 | Stadler et al.36 |
| Phase II, randomized (NCT01121406) | Volasertib vs single-agent chemotherapy | Volasertib 300 mg or investigator's choice of paclitaxel, gemcitabine, topotecan or pegylated liposomal doxorubicin | Advanced ovarian cancer | 109 Volasertib monotherapy (n=54) | Pujade-Lauraine et al.37 |
| Phase II, open label, randomized (NCT00824408) | Volasertib monotherapy vs volasertib+pemetrexed vs pemetrexed monotherapy | Volasertib 300 mg or volasertib 300 mg plus pemetrexed 500 mg/m2, or pemetrexed 500 mg/m2 | Advanced NSCLC | 143 Volasertib monotherapy (n=37) | Ellis et al.38 |
| Phase I, dose escalation (NCT00969761) | Volasertib+cisplatin or carboplatin | Volasertib 100–350 mg+cisplatin 60–100 mg/m2 or carboplatin AUC4–6 | Advanced solid tumors | 61 | Deleporte et al.39 and Dumez et al.40 |
| Phase I, dose escalation (NCT01206816) | Volasertib+afatinib | Volasertib 150–300 mg+afatinib 30–50 mg, days 2–21 (schedule A) or afatinib 50–90 mg, days 2–6 (schedule B) | Advanced solid tumors | 57 | Peeters et al.41 |
| Phase I, dose escalation (NCT01022853) | Volasertib+nintedanib | Volasertib 100–450 mg+nintedanib 200 mg two times daily (except volasertib infusion day) | Advanced solid tumors | 30 | De Braud et al.42 |
| Trials in hematologic malignancies | |||||
| Phase I/II, open label, randomized (NCT00804856) | Volasertib+LDAC vs volasertib monotherapy (phase I) or vs LDACmonotherapy (phase II) | Phase I: volasertib 150–500 mg vs volasertib 150–400 mg+LDAC 20 mg two times dailyPhase II: volasertib 350 mg+LDAC 20 mg two times daily vs LDAC 20 mg two times daily | AML | Phase I: 88 (volasertib monotherapy; n=56) | Bug et al.54,55 and Döhner et al.56,57 |
| Phase II: 87 | |||||
| Phase III, double blind, randomized (NCT01721876; POLO-AML-2) | Volasertib+LDAC vs placebo+LDAC | NS | AML | 660 | Trial is onging; estimated completion date: April 2016a |
| Phase I, dose escalation in Japanese patients (NCT01662505) | Volasertib | NS | AML | 20 | Trial is onging; estimated completion date: July 2014a |
Abbreviations: AML, acute myeloid leukemia; AUC, area under the curve; LDAC, low-dose cytarabine; NS, not stated; NSCLC, non-small-cell lung cancer; q2w, every 2 weeks; q3w, every 3 weeks.
a
Final data collection date for primary outcome measure.