Table 3. List of clinical trials that are currently underway for assessing the efficacy and safety of the AR targets.
| Drugs (Trail ID) | Drugs details | Study population | Study phage (time) |
|---|---|---|---|
| Alpelisib and Enzalutamide (NCT03207529) |
Drug name (Alternative name): Alpelisib (BYL-719; NVP-BYL-719) Type of drug: Small Molecule Mechanism(s) of Action: Phosphatidylinositol 3 kinase alpha inhibitor Generally used for: Phase III Breast cancer; Phase II Non-small cell lung cancer; Phase I/II Colorectal cancer; Head and neck cancer; Multiple myeloma; Oesophageal cancer; Phase I Gastric cancer; Gastrointestinal stromal tumours; Pancreatic cancer; Rectal cancer; Uveal melanoma Drug name (Alternative name): Enzalutamide (Xtandi) Type of drug: Small Molecule Mechanism(s) of Action: Competitive inhibitor of androgen receptor Generally used for: Treatment of castration-resistant prostate cancer. FDA approved on August 31, 2012 |
AR-positive and PTEN positive metastatic breast cancer patients | Phase 1(August 2017 to August 2019) |
| PalbociclibBicalutamide(NCT02605486) |
Drug name (Alternative name): Palbociclib (Ibrance) Type of drug: Small Molecule Mechanism(s) of Action: CDK4/6 inhibitor (DK4/6-cyclin D1 complex initiate's cell-cycle transition from G1 to S phase) Generally used for: Treatment of postmenopausal women with estrogen receptor (ER) positive, HER2 negative advanced breast cancer. Drug name (Alternative name): Bicalutamide (Casodex) Type of drug: Small Molecule Mechanism(s) of Action: Competitive inhibitor of androgen receptor Generally used for: Treatment of men with advanced prostate cancer at stage D2, when there is evidence of metastases (cancer spread) to other areas of the body. |
AR-positive metastatic breast cancer | Phase 2(November 2015- November 2018) |
| Taselisib and Enzalutamide(NCT02457910) |
Drug name (Alternative name): Taselisib Type of drug: Small Molecule Mechanism(s) of Action: PI3K inhibitor Generally used for: Treatment of HER2-negative, hormone receptor positive metastatic breast cancer patients. |
AR-positive metastatic TNBC | Phase 2(June 2015 to December 2019) |
| Enzalutamide Trastuzumab (NCT02091960) |
Drug name (Alternative name): Trastuzumab (Herceptin) Type of drug: Monoclonal antibody Mechanism(s) of Action: Trastuzumab binds to the HER2 (or c-erbB2) proto-oncogene Generally used for: Treatment of HER2+ metastatic (spread) breast cancer. |
AR-positive, HER2 amplified metastatic or locally advanced breast cancer | Phase 2(August 2014 to February 2017) |
| Enzalutamide and Taxol (NCT02689427) |
Drug name (Alternative name): Taxol (Paclitaxel) Type of drug: Small Molecule Mechanism(s) of Action: It binds to beta-tubulin subunits of microtubules and inhibits microtubule growth. Generally used for: Treatment of breast, ovarian, lung, bladder, prostate, melanoma, esophageal tumor |
AR-positive TNBC, stage I–III breast cancer (neoadjuvant therapy) | Phase 2(September 2016 to September 2020) |
| Enzalutamide (NCT02750358) |
Drug name (Alternative name): Enzalutamide (Xtandi) Type of drug: Small Molecule Mechanism(s) of Action: Competitive inhibitor of androgen receptor Generally used for: Treatment of castration-resistant prostate cancer. FDA approved on August 31, 2012 |
AR-positive TNBC, stage I–III breast cancer (adjuvant therapy) | Phase 2(May 2016 to May 2019) |
| Abiraterone Acetate (NCT00755885) |
Drug name (Alternative name): Abiraterone Acetate(Zytiga) Type of drug: Small Molecule Mechanism(s) of Action: Inhibitor of the steroidal enzyme CYP17A1 Generally used for: Treatment of metastatic castration-resistant prostate cancer who have already received prior chemotherapy containing docetaxel. |
Postmenopausal Women With Advanced or Metastatic Breast Cancer | Phase 2(October 2008 completed on June 2016) |
| AZD8186 (NCT01884285) |
Drug name (Alternative name): AZD8186 Type of drug: Small Molecule Mechanism(s) of Action: Phosphatidylinositol-4, 5-bisphosphate 3-kinase, catalytic subunit beta (PIK3CB; PI3Kb) and delta (PIK3CD; PI3Kd) inhibitor Generally used for: AZD8186 effectively inhibits growth of prostate and TNBC tumors |
Advanced TNBC | Phase 1(July 2013 to September 2019) |
| Orteronel (NCT01990209) |
Drug name (Alternative name): Orteronel Type of drug: Small Molecule Mechanism(s) of Action: Orteronel (TAK-700) is a nonsteroidal CYP17A1 inhibitor Generally used for: Treatment of Prostate Cancer |
AR-positive metastatic breast cancer | Phase 2(March 2014 to March 2018) |
| VT-464 (NCT02580448) |
Drug name (Alternative name): Seviteronel (VT-464) Type of drug: Small Molecule Mechanism(s) of Action: Nonsteroidal CYP17A1 inhibitor Generally used for: Treatment for prostate cancer |
Advanced breast cancer. Phase I: TNBC or ER-positive, HER2 negativePhase II: AR-positive TNBC or ER-positive, HER2 negative | Phase 2(August 2015 to July 2017) |
| GTx-024 (NCT02368691) |
Drug name (Alternative name): Enobosarm (GTx-024) Type of drug: Small Molecule Mechanism(s) of Action: Non-steroidal selective androgen receptor modulator (SARM) Generally used for: Treatment of Stress Urinary Incontinence and Triple Negative Breast Cancer. |
AR-positive advanced TNBC | Phase 2(June 2015 completed on December 2016) |
| Pembrolizumab and Enobosarm (NCT02971761) |
Drug name (Alternative name): Pembrolizumab Type of drug: Humanized monoclonal antibody Mechanism(s) of Action: It targets the programmed cell death 1 (PD-1) receptor Generally used for: Treatment of unresectable or metastatic melanoma Drug name (Alternative name): Enobosarm (GTx-024) Type of drug: Small Molecule Mechanism(s) of Action: Non-steroidal selective androgen receptor modulator (SARM) Generally used for: Treatment of Stress Urinary Incontinence and Triple Negative Breast Cancer. |
Androgen Receptor Positive Metastatic Triple Negative Breast Cancer patients | Phase 2(April 2017to June 2018) |