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. 2020 May 1;13:41. doi: 10.1186/s13045-020-00880-8

Table 2.

Clinical trials of CDK4/6 inhibitors in other tumors

CDK inhibitors Study ID Phase Lines Patients Regimens Efficacy
Palbociclib NCT01209598 [47] II Non-first line Advanced WD/DDLS Palbociclib (n = 60) PFS at 12 weeks 57.2%; mPFS 17.9 weeks
NCT02101034 [46] II Non-first line HNSCCs Palbociclib + cetuximab (n = 62) ORR 39% (in platinum-resistant patients), ORR 19% (in cetuximab-resistant patients)
NCT01037790 (recruiting) II UK RB/germ cell tumors Palbociclib (n = 205) PFS at 6 months 28%; mPFS 11 weeks
NCT01536743 (active, not recruiting) II Non-first line Ovarian epithelial carcinoma Palbociclib (n = 26) PFS at 6 months 15%
NCT00420056 [48] Ib UK MCL Palbociclib (n = 17) 6% CR, 12% PR, 41% SD, mPFS 4.0 m
Ribociclib CLEE011X2105 [45] Ib/II Non-first line BRAF V600-mutant melanoma Ribociclib (n = 18) 2 PR, 6 SD
CMEK162X2114 [49] Ib/II UK NRAS-mutant melanoma Ribociclib + binimetinib (n = 22) 7 PR, 11 SD, 33% had 20–30% tumor shrinkage
Abemaciclib NCT01394016 [44] I UK Breast cancer; NSCLC; Melanoma; Glioblastoma; CRC Abemaciclib (n = 225) Breast cancer (n = 47) 23% PR, 47% SD, 23% ORR, 49% CBR, 70%DCR, mPFS 5.8 m; NSCLC (n = 68), 3% PR, 46% SD, 3% ORR, 49% DCR, mPFS 2.0 m; melanoma (n = 26) 4% PR, 23% SD, 4% ORR, 27% DCR; glioblastoma (n = 17) 18% SD, 18% DCR; CRC (n = 15) 13% SD, 13% DCR
NCT02014129 [50] I Non-first line Various advanced cancer Abemaciclib (n = 12) tumor size changed from 35% decrease to 25% increase, > 30% tumor shrinkage in 2 patients

WD/DDLS well-differentiated or dedifferentiated liposarcoma, HNSCCs head and neck squamous-cell carcinomas, Rb retinoblastoma, MCL mantle cell lymphoma, NSCLC non-small-cell lung cancer, CRC colorectal cancer, UK unknown, PFS progression-free survival, OS overall survival, ORR objective response rate, DCR disease control rate, CR complete response, PR partial response, SD stable disease, HR hazard ratio