Table 3.
List of ongoing clinical trials with CDK4/6 inhibitors in combination with one or more other therapies
| Combination | Dosing schedule | Disease | Phase | Identifier | |
|---|---|---|---|---|---|
| Palbociclib | Trastuzumab-DM1 | Palbociclib days 5–18 (21 day cycle) | HER2+ breast cancer | Ib | NCT1976169 |
| (HER2 antibody) | Trastuzumab day 1 | ||||
|
| |||||
| Tucatinib (HER2i) | Palbociclib days 1–21 (28 day cycle) | HR+, HER2+ breast cancer | Ib/II | NCT03054363 | |
| + Letrozole (aromatasei) | Letrozole and Tucatinib days 1–28 | ||||
|
| |||||
| Anastrozole(aromatasei) | Palbociclib days 1–21 (28 day cycle) | HR+, HER2+ breast cancer | I/II | NCT03304080 | |
| + Trastuzumab | Anastrozole days 1–28 | ||||
| +Pertuzumab (HER2i) | Trastuzumab and Pertuzumab once every 21 days | ||||
|
| |||||
| Baxedoxifene (ER modulator) | Not stated | HR+ breast cancer | Ib/II | NCT02448771 | |
|
| |||||
| SAR439859 (ER degrader) | Palbociclib days 1–21 (28 day cycle) | ER+ breast cancer | I/II | NCT03284957 | |
| SAR439859 days 1–28 | |||||
|
| |||||
| GDC-0810 (ER downregulator) | Palbociclib days 1–21 (28 day cycle) | ER+/HER2− breast cancer | I/II | NCT01823835 | |
| GDC-0810 days 1–28 | |||||
|
| |||||
| Gedatolisib (PI3K/mTORi) | Palbociclib days 1–21 (28 day cycle) | ER+/HER2− breast cancer | I | NCT02626507 | |
| +Fulvestrant (ER antagonist) | Gedatolisib days 1, 7, 14, 21; Fulvestrant day 1 | ||||
|
| |||||
| Gedatolisib (PI3K/mTORi) | Palbociclib days 1–21 (28 day cycle) | Solid tumors | I | NCT03065062 | |
| Gedatolisib days 1, 7, 14, and 21 | |||||
|
| |||||
| Copanlisib (PI3Ki) + Letrozole | Palbociclib days 1–21 (28 day cycle) | HR+, HER2− breast cancer | Ib/II | NCT03128619 | |
| Copanlisib days 1, 8, and 15; Letrozole days 1–28 | |||||
|
| |||||
| GDC-0077 (PI3Ki) + Letrozole | Palbociclib days 1–21 (28 day cycle) | PIK3CA mutant, HR+, HER2− breast cancer | I/II | NCT03006172 | |
| GDC-0077 and Letrozole days 1–28 | |||||
|
| |||||
| AZD2014 (mTORC1/2i) | Not stated | ER+ breast cancer | I/II | NCT02599714 | |
| +Fulvestrant | |||||
|
| |||||
| Everolimus (mTORi) | Palbociclib days 1–21 (28 day cycle) | ER+, HER2− breast cancer | Ib/IIa | NCT02871791 | |
| + Exemestane (aromatasei) | Everolimus and Exemestane days 1–28 | ||||
|
| |||||
| PD-0325901 (MEKi) | Palbociclib and PD-0325901 days 1–21 (28 day cycle) | KRAS mutant non-smallcell lung cancer, solid tumors | I/II | NCT02022982 | |
|
| |||||
| Binimetinib (MEKi) | Palbociclib days 1–21 (28 day cycle) | KRAS mutant non-small cell lung cancer | I/II | NCT03170206 | |
| Binimetinib days 1–28 | |||||
|
| |||||
| Neratinib (pan-ERBBi) | Palbociclib and Neratinib days 1–21 (28 day cycle) | EGFR, HER2/3/4amplified/mutated advanced cancers | I | NCT03065387 | |
|
| |||||
| Ibrutinib (BTKi) | Palbociclib days 1–21 (28 day cycle) | Mantle cell lymphoma | I | NCT02159775 | |
| Ibrutinib days 1–28 | |||||
|
| |||||
| Erdafitinib (FGFRi) | Palbociclib days 1–21 (28 day cycle) | ER+/HER2−/FGFRamplified breast cancer | 1 | NCT03238196 | |
| + Fulvestrant | Erdafitinib days 1–28; Fulvestrant day 1 | ||||
|
| |||||
| Cetuximab (EGFRi) | Palbociclib days 1–21 (28 day cycle) | Squamous cell carcinoma of the head and neck | II | NCT02499120 | |
| Cetuximab once weekly | |||||
|
| |||||
| Sorafenib (RTKi) or Decitabine or Dexamethasone | Palbociclib days 1–21 (28 day cycle);Sorafenib days 1–28 | Relapsed and refractory leukemias | I | NCT03132454 | |
| Palbociclib days 1–7 (28 day cycle);Decitabine days 8–12 | |||||
| Palbociclib days 1–21 (28 day cycle);Dexamethasone days 1–4 and days 15–18 | |||||
|
| |||||
| Bicalutamide (anti-androgen) | Palbociclib days 1–21 (28 day cycle) | AR+ breast cancer | I/II | NCT02605486 | |
| Bicalutamide days 1–28 | |||||
|
| |||||
| Anastrozole (aromatasei) | Palbociclib days 1–21 (28 day cycle) | HER2− breast cancer | II | NCT02942355 | |
| Anastrozole days 1–28 | |||||
|
| |||||
| Tamoxifen (anti-mitotic) | Palbociclib days 1–21 (28 day cycle) | HR+, HER2− breast cancer | II | NCT02668666 | |
| Tamoxifen days 1–28 | |||||
|
| |||||
| Cisplatin or Carboplatin | Palbociclib days 2–22 (28 day cycle) | Advanced solid tumors | I | NCT02897375 | |
| Cisplatin or carboplatin day 1 | |||||
|
| |||||
| Carboplatin | Palbociclib days 1–14 (21 day cycle) | Squamous cell carcinoma of the head and neck | II | NCT03194373 | |
| Carboplatin day 1 | |||||
|
| |||||
| 5-FU (nucleotide analog) | Palbociclib days 1–7 (14 day cycle) | Advanced solid tumors | I | NCT01522989 | |
| + Oxaliplatin (platinum-based) | 5-fu/Oxaliplatin day 8 | ||||
|
| |||||
| Bortezomib (proteasomei) | Palbociclib days 1–12 (21 day cycle) | Mantle cell lymphoma | I | NCT01111188 | |
| Bortezomib days 8,11,15,18 | |||||
|
| |||||
| Paclitaxel (anti-mitotic) | Palbociclib days 1–21 (28 day cycle) | Pancreatic ductal adenocarcinoma | I | NCT02501902 | |
| Paclitaxel days 1, 8, 15 | |||||
|
| |||||
| Paclitaxel | Not stated | Advanced breast cancer | I | NCT01320592 | |
|
| |||||
| Avelumab (anti PD-L1) | Palbociclib days 2–22 (28 day cycle) | ER+/HER2− metastatic breast cancer | II | NCT03147287 | |
| + Fulvestrant | Avelumab once every two weeks; Fulvestrant day 1 | ||||
|
| |||||
| Pembrolizumab (PD-1i) | Palbociclib days 1–21 (28 day cycle) | ER+, HER2− breast cancer | II | NCT02778685 | |
| + Letrozole | Pembrolizumab every 21 days; Letrozole days 1–28 | ||||
|
| |||||
| Ribociclib | Trastuzumab (HER2 antibody) | Ribociclib days 5–18 (21 day cycle);Trastuzumab day 1 | HER2+ breast cancer | I/II | NCT02657343 |
|
| |||||
| LSZ102 (ER degrader) | Not stated | ER+ breast cancer | I | NCT02734615 | |
|
| |||||
| Everolimus (mTORi) | Ribociclib days 1–21 (28 day cycle) | Pancreatic adenocarcinoma | I/II | NCT02985125 | |
| Everolimus days 1–28 | |||||
|
| |||||
| Everolimus + Letrozole | All drugs days 1–28 (28 day cycle) | Endometrial cancer | II | NCT03008408 | |
|
| |||||
| Everolimus | Ribociclib days 1–21 (28 day cycle) | Dedifferentiated liposarcoma andLeiomyosarcoma | II | NCT03114527 | |
| Everolimus days 1–28 | |||||
|
| |||||
| Everolimus | Ribociclib days 1–21 (28 day cycle) | Neuroendocrine tumors | II | NCT03070301 | |
| Everolimus days 1–28 | |||||
|
| |||||
| Everolimus | Ribociclib days 1–21 (28 day cycle) | HR+, HER2− breast cancer | I | NCT01857193 | |
| + Exemestane (aromatasei) | Everolimus + Exemestane days 1–28 | ||||
|
| |||||
| BLY719 (PI3Ki) + Letrozole | Ribociclib days 1–21 (28 day cycle) | ER+ breast cancer | I | NCT01872260 | |
| BLY719 + Letrozole days 1–28 | |||||
|
| |||||
| BLY719 or BKM120 (pan-PI3Ki) | Ribociclib days 1–21 (28 day cycle) | ER+/HER2− breast cancer | I/II | NCT02088684 | |
| + Fulvestrant | BLY719 or BKM120 days 1–28; Fulvestrant day 1 | ||||
|
| |||||
| Trametinib (MEKi) | Not stated | Advanced solid tumors | I/II | NCT02703571 | |
|
| |||||
| MEK162 (MEKi) | Ribociclib days 1–21 (28 day cycle) | NRAS mutant melanoma | Ib/II | NCT01781572 | |
| MEK162 days 1–28 | |||||
|
| |||||
| LGX818 (RAFi) + MEK162 | Ribociclib days 1–21 (28 day cycle) | BRAF dependent advanced solid tumors | I/II | NCT01543698 | |
| LGX818 + MEK162 days 1–28 | |||||
|
| |||||
| EGF816 (EGFRi) | Not stated | EGFR mutant non-smallcell lung cancer | I | NCT03333343 | |
|
| |||||
| Ceritinib (ALKi) | Not stated | ALK positive non-small cell lung cancer | I | NCT02292550 | |
|
| |||||
| Enzalutamide (anti-androgen) | Ribociclib days 1–21 (28 day cycle);Enzalutamide days 1–28 | Prostate Cancer | I/II | NCT02555189 | |
|
| |||||
| Bicalutamide (anti-androgen) | Ribociclib days 1–21 (28 day cycle) | AR+ triple negative breast cancer | I/II | NCT03090165 | |
| Bicalutamide days 1–28 | |||||
|
| |||||
| Carboplatin | Ribociclib days 1–4, 8–11, 15–18 (28 day cycle) | Ovarian cancer | I | NCT03056833 | |
| + Paclitaxel (anti-mitotic) | Paclitaxel + carboplatin days 1, 8, 15 | ||||
|
| |||||
| Paclitaxel | Not stated | Advanced breast cancer | I | NCT02599363 | |
|
| |||||
| Doxorubicin | Ribociclib days 1–7 (21 day cycle) | Advanced soft tissue sarcoma | I | NCT03009201 | |
| Doxorubicin day 10 | |||||
|
| |||||
| Tamoxifen (anti-mitotic) | Ribociclib days 1–21 (28 day cycle) | ER+, HER2− breastcancer | I | NCT02586675 | |
| Tamoxifen days 1–28 | |||||
|
| |||||
| Gemcitabine(nucleotide analog) | Ribociclib days 8–14 (21 day cycle) | Advanced solid tumors | I | NCT03237390 | |
| Gemcitabine days 1, 8 | |||||
|
| |||||
| Docetaxel (anti-mitotic) | Ribociclib days 2–14 (21 day cycle) | Prostate cancer | I/II | NCT02494921 | |
| + Prednisone | Docetaxel and Prednisone days 1–21 | ||||
|
| |||||
| PDR001 (anti-PD1 antibody) | Ribociclib days 1–21 (28 day cycle) | HR+, HER2− breast andovarian cancer | I | NCT03294694 | |
| ± Fulvestrant | PDR001 days 1–28 | ||||
|
| |||||
| Abemaciclib | LY3023414 (PI3K/mTORi) | Not stated | Pancreatic ductal adenocarcinoma | II | NCT02981342 |
|
| |||||
| LY3214996 (ERK1/2i) | Not stated | Advanced solid tumors | I | NCT02857270 | |
|
| |||||
| Ramucirumab (anti-VEGFR2) | Abemaciclib days 1–28 (28 day cycle) | Advanced solid tumors and lymphoma | I | NCT02745769 | |
| Ramucirumab days 1, 15 | |||||
|
| |||||
| Xentuzumab (IGF1/2i) | Abemaciclib daily, Xentuzumab once a week | Advanced solid tumors, HR+ breast cancer | I | NCT03099174 | |
|
| |||||
| LY3039478 (Notchi) | Both drugs daily | Advanced solid tumors | Ib | NCT02787495 | |
|
| |||||
| Exemestane (aromatasei) or Exemestane + Everolimus or LY3032414 + Fulvestrant or Letrozole (aromatasei) or Anastrozole (aromatasei) or Tamoxifen (anti-mitotic) or Trastuzumab (HER2 antibody) | All drugs daily | Metastatic breast cancer | Ib | NCT02057133 | |
|
| |||||
| Anastrozole or Letrozole | All dugs daily | HR+, HER2− breast cancer | III | NCT02246621 | |
|
| |||||
| Tamoxifen | Both drugs daily | HR+, HER2− breast cancer | II | NCT02747004 | |
|
| |||||
| Premetrexed (anti-folate) or Gemcitabine or Ramucirumab or LY3023414 or Pembrolizumab (PD-1i) | Abemaciclib daily (21 day cycle) | Non-small cell lung cancer | I | NCT02079636 | |
| Premetrexed day 1 | |||||
| Gemcitabine days 1, 8 | |||||
| Ramucirumab days 1, 8 | |||||
| Pembrolizumab day 1 | |||||
|
| |||||
| LY3300054 (anti-PD-L1) | Abemaciclib daily (28 day cycle); LY3300054 days 1, 15 | Advanced solid tumors | I | NCT02791334 | |