Table 5.
Registered clinical trials based on autophagy modulation in various diseases.
| NCT number | Study Design | Title | Regimen | Study Start/Study End | Result |
|---|---|---|---|---|---|
| NCT04160455 | Observational model: cohort | Study of autophagy and the effects of GALIG gene products in HIV-1 infected patients who are under antiretroviral therapy since primary-infection, chronic phase, or never treated. | HIV-1 infected patients under antiretroviral therapy since primary-infection, chronic phase, or never treated | November 7, 2019/November 7, 2029 | Recruiting |
| NCT04138134 | Observational model: cohort | Autophagy and venous endothelial function | Spermidine | December 1, 2019/June 1, 2020 | Not yet recruiting |
| NCT03979651 | NR, OL | MEK and autophagy inhibition in metastatic/locally advanced, unresectable neuroblastoma RAS (NRAS) melanoma | Trametinib plus HCQ | September 30, 2019/March 31, 2022 | Ongoing |
| NCT00786682 | Phase II, NR, OL | Docetaxel and hydroxychloroquine in treating patients with metastatic prostate cancer | Docetaxel and HCQ | December 2008–October 2012 | The study was stopped due to lack of improved efficacy compared to historical controls. |
| NCT00765765 | Phase I/II, NR, OL | Ixabepilone and hydroxychloro-quine in treating patients with metastatic breast cancer | Ixabepilone and HCQ | February 2009–December 2012 | The study was closed early due to slow accrual |
| NCT00969306 | Phase I, NR, OL | Chloroquine as an antiautophagy drug in stage IV small cell lung cancer (SCLC) patients | Chloroquine | September 2013–June 2016 | Terminated but no results posted |
| NCT03037437 | Phase II, NR, OL | Sorafenib induced autophagy using hydroxychloroquine in hepatocellular cancer | Sorafenib + HCQ | February 16, 2017–December 2020 | Ongoing |
| NCT01480154 | Phase I, NR, OL | Akt inhibitor MK2206 and hydroxychloroquine in treating patients with advanced solid tumors, melanoma, prostate or kidney cancer | MK2206 + HCQ | November 23, 2011–December 2019 | (Mehnert et al., 2019) |
| NCT01510119 | Phase I/II, NR, OL | Autophagy inhibition to augment mTOR Inhibition: A Phase I/II Trial of RAD001 and hydroxychloroquine in patients with previously treated renal cell carcinoma | RAD001 (everolimus) + HCQ | September 2011–January 2017 | (Haas et al., 2019) |
| NCT01023737 | Phase I, NR, OL | Hydroxychloroquine + Vorinostat in advanced solid tumors | HCQ + Vorinostat | November 2009–September 2020 | (Patel et al., 2016) |
| NCT03598595 | Phase I/II, NR, OL | Gemcitabine, docetaxel, and hydroxychloroquine in treating participants with recurrent or refractory osteosarcoma | Gemcitabine, Docetaxel, and HCQ | January 28, 2019–March 2, 2020 | Ongoing |
| NCT02631252 | Phase I, NR, OL | Phase I Study of mitoxantrone and etoposide combined with hydroxychloroquine, for relapsed acute myelogenous leukemia | Mitoxantrone and Etoposide and HCQ | August 18, 2016–October 2, 2017 | Terminated due to inability to accrue. |
| NCT03774472 | Phase I, NR, OL | Hydroxychloroquine, palbociclib, and letrozole before surgery in treating participants with estrogen receptor positive, HER2 negative breast cancer | HCQ, Palbociclib, and Letrozole | August 20, 2018–December 31, 2020 | Ongoing |
| NCT02339168 | Phase I, NR, OL | Enzalutamide and metformin-hydrochloride in treating patients with hormone-resistant prostate cancer | Enzalutamide and Metformin-Hydrochloride | June 2016–July 2020 | Ongoing |
| NCT01594242 | Phase I, NR, OL | Autophagy induction after bortezomib for myeloma | Bortezomib | July 10, 2012–March 2, 2015 | Completed but no results are available |
| NCT03700424 | Phase II, R, quadruple-blind | Inflammation reduction by Trehalose administration (in acute coronary syndrome) | Trehalose vs normal saline infusion weekly (15 g/week) for a period of 12 weeks | July 7, 2019–June 2020 | Ongoing |
| NCT01266057 | Phase I, NR, OL | Sirolimus or vorinostat and hydroxychloroquine in advanced cancer | Sirolimus or Vorinostat and HCQ |
April 28, 2011–February 2021 | Ongoing |
| NCT02378532 | Phase I, NR, OL | The addition of chloroquine to chemoradiation for glioblastoma | Chloroquine + temozolomide + chemoradiation | August 2016–June 2019 | Ongoing (still recruiting) |
| NCT01006369 | Phase II, NR, OL | Hydroxychloroquine, capecitabine, oxaliplatin, and bevacizumab in treating patients with metastatic colorectal cancer | HCQ, Capecitabine, Oxaliplatin, and Bevacizumab | May 2009–April 27, 2016 | Completed but results are not yet available |
| NCT03309007 | Phase III, R, quadruple-blind | A double-blind, placebo-controlled trial of anti-aging, pro-autophagy effects of metformin in adults with prediabetes | Metformin Placebo | September 1, 2017–July 31, 2021 | Active, not recruiting |
| NCT02042989 | Phase I, NR, OL | MLN9708 and Vorinostat in patients with advanced p53 mutant malignancies | MLN9708 and Vorinostat | June 27, 2014–June 2022 | Active, not recruiting |
| NCT00728845 | Phase I/II, NR, OL | Hydroxychloroquine, carboplatin, paclitaxel, and bevacizumab in recurrent advanced nonsmall cell lung cancer | HCQ, Carboplatin, Paclitaxel, and Bevacizumab | June 16, 2008–December 21, 2010 | Terminated due to slow accrual |
| NCT03754179 | Phase I/II, R, OL | Dabrafenib/trametinib/hydroxychloroquine for advanced pretreated BRAF V600 mutant melanoma | Dabrafenib/Trametinib/HCQ | January 23, 2018–December 2020 | Recruiting |
| NCT02316340 | Phase II, R, OL | Vorinostat Plus hydroxychloroquine vs regorafenib in colorectal cancer | Vorinostat + HCQ vs Regorafenib | February 2015–September 2020 | Active, not recruiting |
| NCT02432417 | Phase II, R, OL | The addition of chloroquine to chemoradiation for glioblastoma, | Chloroquine + Chemoradiation | January 2020–January 2024 | Not yet recruiting |
| NCT02257424 | Phase I/II, NR, OL | Dabrafenib, trametinib, and hydroxychloroquine in patients with advanced BRAF mutant melanoma | Dabrafenib, Trametinib and HCQ | October 2014–October 2026 | Active, recruiting |
| NCT02421575 | Phase I, NR, OL | Hydroxychloroquine in blocking autophagy in patients with prostate cancer undergoing surgery or active surveillance | HCQ | July 2012–February 26, 2016 | Terminated due to slow accrual |
| NCT01206530 | Phase I/II | FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer | HCQ, Oxaliplatin, Leuco-vorin, 5-fluorouracil, Bevacizumab | September 2010 –September 2017 | (Loaiza-Bonilla et al., 2015) |
| NCT00962845 | Phase I, NR, OL | Hydroxychloroquine in patients with stage III or stage IV melanoma that can be removed by surgery | HCQ | September 2010–May 2013 | Early Phase I is completed. Last update September, 2018. https://ichgcp.net/es/clinical-trials-registry/NCT00962845 |
| NCT01144169 | Phase I, NR, O | Study of hydroxychloroquine before surgery in patients with primary renal Cell carcinoma | HCQ | October 2010–September 2016 | Terminated due to barriers to accrual such as delay until surgery and additional preoperative visits |
| NCT03094546 | Phase III, R, triple-blind | Polyamine-enriched diet in elderly individuals with subjective cognitive decline | Polyamine-rich diet | June 2019 – June 2020 | (Wirth et al., 2019) |
| NCT01583283 | A Phase I/II, Open Label, Multi-center Study | Study of ACY-1215 in combination with lenalidomide, and dexamethasone in multiple myeloma | Ricolinostat (ACY-1215) Lenalidomide Dexamethasone | July 12, 2012–December 31, 2019 | (Yee et al., 2016) |
| NCT01997840 | Phase 1B/2 Multi-Center, Open Label, Dose-escalation Study | ACY-1215 (ricolinostat) in combination with pomalidomide and low-dose dex in relapsed-and-refractory multiple myeloma | ACY-1215 (ricolinostat) in combination with pomalidomide and dexamethasone | March 1, 2014–January 27, 2021 | Active, not recruiting |
| NCT02189343 | Phase 1b Multi-Center, Open Label, Dose-Escalation Study | Phase 1b Study evaluating ACY-1215 (ricolinostat) in combination with pomalidomide and dexamethasone in relapsed or relapsed-and-refractory multiple myeloma | ACY-1215 (Ricolinostat) Pomalidomide Dexamethasone | September 15, 2014–January 30, 2019 | Active, not recruiting |
R, randomized; DB, double-blind; OL, open label; PC, placebo-controlled; MC, multicenter; N, number of patients; d, day; w, week, m, month; RT, Radiotherapy; PL, placebo; HCQ, hydroxychloroquine; CQ, chloroquine; OS, overall survival; ORR, objective response rate; CR, complete response; PR, partial response; MR, minor response; SD, stable disease; PFS, progression-free survival.