Table 8.
Clinical trials of natural products to as anti-cancer agents (https://clinicaltrials.gov).
| Compound | ClinicalTrials.gov Identifier | Type of study | Characteristics of patients (n) | Dose and time of treatment | Condition | Phase | Additional Refs |
|---|---|---|---|---|---|---|---|
| Trabectedin | NCT01343277 | A multicenter, open- label, randomized, active- controlled, parallel- group | trabectedin group (n = 378) or dacarbazine group (n = 172) | trabectedin Arm: 1.5 mg/m2 as a 24 h IV infusion q3wk. |
advanced liposarcoma, Leiomyosarcoma | phase 3 | [100] |
| Sylmarin (mixture of flavonolignans consisting of silibinin, isosilibinin, silychristin, silidianin) | NCT03130634 | open-label, randomized, comparative, double arm, single center | sylmarin group or control group; n = 70 | during six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150 mg) 3x daily from day 1 to day 7 during one cycle of treatment. | Metastatic, colorectal cancer | phase 4 | |
| Silibin-Phytosome | NCT00487721 | non-Randomized | silibin-phytosome group or control group; n = 12 | 13 g daily, in three divided doses for 2–10 weeks. | prostate cancer | phase 2 | |
| Xanthohumol | NCT02432651 | randomized | 2 mg group, 12 mg group and 24 mg group, placebo; n = 64 | 2/12/24 mg xanthohumol at breakfast, lunch, and dinner for 3 weeks. | oxidative Stress | Phase 1 | |
| Catechin (Sinecatechins 10%) | NCT02029352 | randomized double-blinded | catechin group or placebo group; n = 42 | twice daily (morning and evening) in a thin layer to the tumor including 5 mm of the surrounding skin | carcinoma | Phase 2/3 | |
| Lycopene | NCT00068731 | randomized double-blinded | lycopene group or placebo group; n = 47 | twice daily on days 1–28. Courses repeat every 28 days for at least 4 months | prostate cancer | phase 2 | |
| Catechin epigallocatechin-3-gallate (EGCG) | NCT02577393 | randomized double-blinded | prophylactic EGCG group, therapeutic EGCG group, placebo; n = 83 | 440 lmol/L | lung neoplasms | phase 2 | |
| Curcumin | NCT01740323 | randomized double-blinded | resveratrol group (n = 15) or placebo group (n = 15) | 500 mg BID | breast cancer | phase 2 | |
| Resveratrol | NCT00256334 | randomized, placebo- controlled, double blind | resveratrol group, placebo group; n = 11 | one of four dose cohorts: plant-derived resveratrol tablets at a dose of 80 mg/day, plant-derived resveratrol tablets at a dose of 20 mg/day, Grape Powder (GP) at a dose of 120 g/day, and GP at a dose of 80 g/day. | colon cancer | phase 1 | |
| Resveratrol | NCT00920803 | double-blind, randomized | resveratrol group, placebo group; n = 9 | 5 g once daily for 14 days | neoplasms, colorectal | phase 1 | |
| Resveratrol | NCT00433576 | non-Randomized | n = 20 | STAGE II: Patients receive oral resveratrol on days 1–8. Patients undergo colorectomy on day 9 | aAdenocarcinoma of the Colon Adenocarcinoma of the Rectum Stage I Colon Cancer Stage I Rectal Cancer Stage II Colon Cancer Stage II Rectal Cancer Stage III Colon Cancer Stage III Rectal Cancer | phase 1 | |
| Sulforaphane | NCT00982319 | randomized double-blinded | n = 34 | 100 μmols of sulforaphane dissolved in 150 mL mango juice once a day for 14 days | breast cancer | phase 2 | |
| Romidepsin | NCT00106418 | non-randomized, multicenter, open-label trial | n = 35 | 13 mg/m^2 of romidepsin intravenously over 4 h on Days 1, 8, and 15 of each 28-day cycle | prostate cancer | phase 2 | |
| Romidepsin | NCT01353664 | open-label, single-arm study | n = 19 | same dose, infusion time and frequency used for the last dose of romidepsin given | lung cancer | phase 2 | |
| Omacetaxine mepesuccinate | NCT00375219 | open-label | chronic phase group (n = 62), accelerated phase (n = 20), blast phase (n = 21) | 1.25 mg/m^2 subcutaneously, twice daily for 14 consecutive days every 28 days until response | chronic myeloid leukemia | phase 2 | |
| Picropodophyllotoxin | NCT01466647 | open single-center, explorative | n = 12 | a repeated BID treatment for 14 days, followed by a 7-day observation period for two treatment periods | non-small Cell Lung Cancer | phase 1 | |
| Picropodophyllotoxin | NCT01561456 | open label, randomized, multi-center | n = 100 | oral suspension at 400 mg twice daily for 21 days per cycle | non-small-cell Lung Cancer Squamous Cell Carcinoma Adenocarcinoma of the Lung | phase 2 | |
| Marizomib/salinosporamide A | NCT00396864 | multicenter, open-label study | n = 51 | injection at doses ranging from 0.0125 to 0.8 mg/m2 over 1–10 min on Day 1, Day 8, Day 15 of each 28-day Cycle; 11 dose cohorts during dose-escalation | cancer lymphomas | phase 1 | |
| Plitidepsin | NCT00229203 | non-randomized, multicentre, open-label | plitidepsin group (n = 32) and plitidepsin with dexamethasone (n = 19) | 5 mg/m2, 3-h infusion every 2 weeks | Multiple Myeloma | phase 2 | |
| Plitidepsin | NCT01102426 | non-randomized, multicentre, open-label | plitidepsin+ dexamethasone Group (n = 171), dexamethasone (n = 84) |
5 mg/m2 intravenously (i.v.) over 3 h on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least 1 h before plitidepsin infusion. | multiple myeloma | phase 3 | |
| Plocabulin/PM 060184 | NCT03427268 | open-label, multicentre study | PM 060184 group (n = 32) | 9.3 mg/m2 PM 060184 i.v. as a 30-min infusion via a central or peripheral venous catheter; It administered on Day 1 and Day 8 q3wk | colorectal cancer | phase 2 | |
| Bryostatin 1 | NCT00003968 | open Label | n = 35 | bryostatin 1 IV over 1 h on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion. | kidney cancer | phase 2 | |
| Tetrodotoxin | NCT00725114 | multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-design | tetrodotoxin group, placebo group; n = 165 | 30 μg twice daily for 4 days | cancer pain | phase 3 | |
| Tivantinib | NCT01755767 | randomized, double-blind study | tivantinib 240 mg BID Cohort group (n = 28), Placebo Matching 240 mg BID Cohort group (n = 15), Tivantinib 120 mg BID Cohort group (n = 226), Placebo Matching 120 mg BID Cohort group (n = 114) | the dosage of 120/240 mg tablets administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 240/480 mg. | hepatocellular carcinoma | phase 3 | |
| Tivantinib | NCT02029157 | randomized double-blind, placebo-controlled | tivantinib 120 mg BID Cohort group (n = 134), Placebo Matching 120 mg BID Cohort group (n = 61) | twice-a-day oral tivantinib (120 mg bid) | liver cancer | phase 3 | [146] |
| Gossypol | NCT00540722 | Open-label | gossypol group (n = 56) | once daily on days 1–21. Treatment repeats every 28 days | glioblastoma | phase 2 | |
| Epothilone D | NCT00077259 | open-label | n = 16–69 | drug IV over 90 min on days 1, 8, and 15. Courses repeat every 28 days | colorectal cancer | phase 2 | |
| Dolastatin 10 | NCT00003677 | open-label | n = 9 | IV bolus once every 21 days. | pancreatic cancer | phase 2 |