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| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
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Colorectal neoplasms are the third most common malignancies in the United States. Patients with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The response rates to chemotherapy range from 35-40%.
Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations also demonstrate that genistein may augment growth inhibition when combined with chemotherapeutic agents of 5-Fluorouracil and platinum compounds.
Based on pre-clinical data the investigators hypothesize that combining genistein with the standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve response rates in patients. The aim of the study is to add genistein to the regimens of FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.
OBJECTIVES:
Primary
Secondary:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genistein | Experimental | Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein will be administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genistein | Drug | Genistein combined with FOLFOX or FOLFOX-Avastin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle. | up to 6 months |
| Percent Change in Tumor Size | Percent change in tumor size after cycle 6. Each cycle is 21 days. | end of Cycle 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate RECIST Criteria | Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Not provided
Inclusion Criteria:
Adult male and female patients ≥18 years old
Have pathologically confirmed colon or rectal carcinoma
Have metastatic (stage IV) disease
Have a plan by treating physician to receive FOLFOX or FOLFOX-Avastin
Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Have adequate hematopoietic, hepatic and renal function
Hematopoietic function
Hepatic Function
Renal Function
Are not pregnant and do not plan to become pregnant
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall F Holcombe, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Sofya Pintova, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8461861 | Background | DeCosse JJ, Ngoi SS, Jacobson JS, Cennerazzo WJ. Gender and colorectal cancer. Eur J Cancer Prev. 1993 Mar;2(2):105-15. doi: 10.1097/00008469-199303000-00003. | |
| 9718216 | Background | Hebert-Croteau N. A meta-analysis of hormone replacement therapy and colon cancer in women. Cancer Epidemiol Biomarkers Prev. 1998 Aug;7(8):653-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Genistein | Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Genistein | Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle. | Posted | Number | events | up to 6 months |
|
|
6 months
AEs collected for when subjects on Genistein alone and when subjects on Genistein and Chemotherapy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genistein | Genistein 60mg/day orally for 4 days before chemotherapy. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sofya Pintova | Icahn School of Medicine at Mount Sinai | 212-824-8461 | Sofya.Pintova@mountsinai.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2016 | Mar 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2013 | Mar 25, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
Not provided
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| end of Cycle 6 |
| Number of Participants With an Overall Response Rate (ORR) | Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period | up to 50 months |
| Best Overall Response Rate RECIST Criteria | Best Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions. PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions. | up to 50 months |
| Number of Participants With Best Overall Response Rate (ORR) | The number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. | up to 50 months |
| Progression Free Survival (PFS) | Patients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse. | up to 50 months |
| Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months | Patients monitored for progression during the study period and 1 year following. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse. | 6 month and 12 month |
| Overall Survival (OS) | Overall Survival - Number of months still living since baseline | up to 50 months |
| 4797262 | Background | Haenszel W, Berg JW, Segi M, Kurihara M, Locke FB. Large-bowel cancer in Hawaiian Japanese. J Natl Cancer Inst. 1973 Dec;51(6):1765-79. doi: 10.1093/jnci/51.6.1765. No abstract available. |
| 1917235 | Background | Hu JF, Liu YY, Yu YK, Zhao TZ, Liu SD, Wang QQ. Diet and cancer of the colon and rectum: a case-control study in China. Int J Epidemiol. 1991 Jun;20(2):362-7. doi: 10.1093/ije/20.2.362. |
| 21590181 | Background | Nishi M, Yoshida K, Hirata K, Miyake H. Eating habits and colorectal cancer. Oncol Rep. 1997 Sep-Oct;4(5):995-8. doi: 10.3892/or.4.5.995. |
| 8449821 | Background | Kono S, Imanishi K, Shinchi K, Yanai F. Relationship of diet to small and large adenomas of the sigmoid colon. Jpn J Cancer Res. 1993 Jan;84(1):13-9. doi: 10.1111/j.1349-7006.1993.tb02777.x. |
| 8942431 | Background | Witte JS, Longnecker MP, Bird CL, Lee ER, Frankl HD, Haile RW. Relation of vegetable, fruit, and grain consumption to colorectal adenomatous polyps. Am J Epidemiol. 1996 Dec 1;144(11):1015-25. doi: 10.1093/oxfordjournals.aje.a008872. |
| 8200067 | Background | Pereira MA, Barnes LH, Rassman VL, Kelloff GV, Steele VE. Use of azoxymethane-induced foci of aberrant crypts in rat colon to identify potential cancer chemopreventive agents. Carcinogenesis. 1994 May;15(5):1049-54. doi: 10.1093/carcin/15.5.1049. |
| Background | Helms JR and Gallaher DD, The effect of dietary soy protein isolate and genistein on the development of preneoplastic lesions (aberrant crypts) in rats. 1995 Cancer Lett:125 |
| 9848506 | Background | Thiagarajan DG, Bennink MR, Bourquin LD, Kavas FA. Prevention of precancerous colonic lesions in rats by soy flakes, soy flour, genistein, and calcium. Am J Clin Nutr. 1998 Dec;68(6 Suppl):1394S-1399S. doi: 10.1093/ajcn/68.6.1394S. |
| 16061678 | Background | Li Y, Ahmed F, Ali S, Philip PA, Kucuk O, Sarkar FH. Inactivation of nuclear factor kappaB by soy isoflavone genistein contributes to increased apoptosis induced by chemotherapeutic agents in human cancer cells. Cancer Res. 2005 Aug 1;65(15):6934-42. doi: 10.1158/0008-5472.CAN-04-4604. |
| 16091008 | Background | Linsalata M, Russo F, Notarnicola M, Guerra V, Cavallini A, Clemente C, Messa C. Effects of genistein on the polyamine metabolism and cell growth in DLD-1 human colon cancer cells. Nutr Cancer. 2005;52(1):84-93. doi: 10.1207/s15327914nc5201_11. |
| 21639915 | Background | Qi W, Weber CR, Wasland K, Savkovic SD. Genistein inhibits proliferation of colon cancer cells by attenuating a negative effect of epidermal growth factor on tumor suppressor FOXO3 activity. BMC Cancer. 2011 Jun 3;11:219. doi: 10.1186/1471-2407-11-219. |
| 8187091 | Background | Miyaki M, Konishi M, Kikuchi-Yanoshita R, Enomoto M, Igari T, Tanaka K, Muraoka M, Takahashi H, Amada Y, Fukayama M, et al. Characteristics of somatic mutation of the adenomatous polyposis coli gene in colorectal tumors. Cancer Res. 1994 Jun 1;54(11):3011-20. |
| 21571909 | Background | Zhang Y, Chen H. Genistein attenuates WNT signaling by up-regulating sFRP2 in a human colon cancer cell line. Exp Biol Med (Maywood). 2011 Jun 1;236(6):714-22. doi: 10.1258/ebm.2011.010347. Epub 2011 May 13. |
| 15896711 | Background | Hwang JT, Ha J, Park OJ. Combination of 5-fluorouracil and genistein induces apoptosis synergistically in chemo-resistant cancer cells through the modulation of AMPK and COX-2 signaling pathways. Biochem Biophys Res Commun. 2005 Jul 1;332(2):433-40. doi: 10.1016/j.bbrc.2005.04.143. |
| 19025644 | Background | Solomon LA, Ali S, Banerjee S, Munkarah AR, Morris RT, Sarkar FH. Sensitization of ovarian cancer cells to cisplatin by genistein: the role of NF-kappaB. J Ovarian Res. 2008 Nov 24;1(1):9. doi: 10.1186/1757-2215-1-9. |
| Background | Yanhong H, et al, Genistein sensitizes ovarian carcinoma cells to chemotherapy by switching the cell cycle progression in vitro. J Medical Colleges of PLA:125-135 |
| 18421054 | Background | Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930. |
| 19998579 | Background | Metzner JE, Frank T, Kunz I, Burger D, Riegger C. Study on the pharmacokinetics of synthetic genistein after multiple oral intake in post-menopausal women. Arzneimittelforschung. 2009;59(10):513-20. doi: 10.1055/s-0031-1296435. |
| 12540402 | Background | Setchell KD, Faughnan MS, Avades T, Zimmer-Nechemias L, Brown NM, Wolfe BE, Brashear WT, Desai P, Oldfield MF, Botting NP, Cassidy A. Comparing the pharmacokinetics of daidzein and genistein with the use of 13C-labeled tracers in premenopausal women. Am J Clin Nutr. 2003 Feb;77(2):411-9. doi: 10.1093/ajcn/77.2.411. |
| 14652284 | Background | Takimoto CH, Glover K, Huang X, Hayes SA, Gallot L, Quinn M, Jovanovic BD, Shapiro A, Hernandez L, Goetz A, Llorens V, Lieberman R, Crowell JA, Poisson BA, Bergan RC. Phase I pharmacokinetic and pharmacodynamic analysis of unconjugated soy isoflavones administered to individuals with cancer. Cancer Epidemiol Biomarkers Prev. 2003 Nov;12(11 Pt 1):1213-21. |
| 15231450 | Background | Fischer L, Mahoney C, Jeffcoat AR, Koch MA, Thomas BE, Valentine JL, Stinchcombe T, Boan J, Crowell JA, Zeisel SH. Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia. Nutr Cancer. 2004;48(2):160-70. doi: 10.1207/s15327914nc4802_5. |
| 16254818 | Background | Ullmann U, Oberwittle H, Grossmann M, Riegger C. Repeated oral once daily intake of increasing doses of the novel synthetic genistein product Bonistein in healthy volunteers. Planta Med. 2005 Oct;71(10):891-6. doi: 10.1055/s-2005-864186. |
| 11756070 | Background | Busby MG, Jeffcoat AR, Bloedon LT, Koch MA, Black T, Dix KJ, Heizer WD, Thomas BF, Hill JM, Crowell JA, Zeisel SH. Clinical characteristics and pharmacokinetics of purified soy isoflavones: single-dose administration to healthy men. Am J Clin Nutr. 2002 Jan;75(1):126-36. doi: 10.1093/ajcn/75.1.126. |
| 31203390 | Derived | Pintova S, Dharmupari S, Moshier E, Zubizarreta N, Ang C, Holcombe RF. Genistein combined with FOLFOX or FOLFOX-Bevacizumab for the treatment of metastatic colorectal cancer: phase I/II pilot study. Cancer Chemother Pharmacol. 2019 Sep;84(3):591-598. doi: 10.1007/s00280-019-03886-3. Epub 2019 Jun 15. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ECOG | The Eastern Cooperative Oncology Group (ECOG) measures level of functioning in terms of daily living abilities: 0-Fully active, able to carry on all pre-disease performance without restriction 1-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg.light house work | Count of Participants | Participants |
|
| Tumor Location | Count of Participants | Participants |
|
| KRAS/NRAS | Count of Participants | Participants |
|
| BRAF V600F | Count of Participants | Participants |
|
| Number of Metastatic Sites | Count of Participants | Participants |
|
|
| Primary | Percent Change in Tumor Size | Percent change in tumor size after cycle 6. Each cycle is 21 days. | Posted | Median | 95% Confidence Interval | Percent change | end of Cycle 6 |
|
|
|
| Secondary | Response Rate RECIST Criteria | Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Posted | Count of Participants | Participants | end of Cycle 6 |
|
|
|
| Secondary | Number of Participants With an Overall Response Rate (ORR) | Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period | Posted | Count of Participants | Participants | up to 50 months |
|
|
|
| Secondary | Best Overall Response Rate RECIST Criteria | Best Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions. PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions. | Posted | Count of Participants | Participants | up to 50 months |
|
|
|
| Secondary | Number of Participants With Best Overall Response Rate (ORR) | The number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. | Posted | Count of Participants | Participants | up to 50 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | Patients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse. | Posted | Median | 95% Confidence Interval | months | up to 50 months |
|
|
|
| Secondary | Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months | Patients monitored for progression during the study period and 1 year following. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 month and 12 month |
|
|
|
| Secondary | Overall Survival (OS) | Overall Survival - Number of months still living since baseline | Posted | Median | 95% Confidence Interval | months | up to 50 months |
|
|
|
| 13 |
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | Genistein and Chemotherapy | Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein administered beginning 4 days prior to chemotherapy. | 0 | 13 | 0 | 13 | 13 | 13 |
| Hot Flashes | General disorders | Systematic Assessment |
|
| Mucositis | General disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thromboembolism | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cold Sensitivity | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | Systematic Assessment | Gastroesophageal reflux disease |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|
|
| Not evaluable |
|
| Title | Measurements |
|---|
|
| Not evaluable |
|