eflornithine has been researched along with Adenomatous Polyposis Coli, Familial in 10 studies
Eflornithine: An inhibitor of ORNITHINE DECARBOXYLASE, the rate limiting enzyme of the polyamine biosynthetic pathway.
eflornithine : A fluoroamino acid that is ornithine substituted by a difluoromethyl group at position 2.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Disease progression was observed in 2 of 54 (3." | 3.11 | Combination of Sulindac and Eflornithine Delays the Need for Lower Gastrointestinal Surgery in Patients With Familial Adenomatous Polyposis: Post Hoc Analysis of a Randomized Clinical Trial. ( Balaguer, F; Boytim, ML; Bruckheimer, EM; Burke, CA; Church, J; Cohen, A; Dekker, E; Du, W; Hüneburg, R; Lim, RM; Lynch, PM; Samadder, NJ; Stoffel, EM; Van Cutsem, E; Wise, PE, 2022) |
| "In this trial involving patients with familial adenomatous polyposis, the incidence of disease progression was not significantly lower with the combination of eflornithine and sulindac than with either drug alone." | 2.94 | Eflornithine plus Sulindac for Prevention of Progression in Familial Adenomatous Polyposis. ( Balaguer, F; Burke, CA; Burn, J; Castells, A; Church, J; Cohen, A; Dekker, E; Ford, M; Gallinger, S; Ginsberg, GG; Grady, WM; Gryfe, R; Gupta, S; Henderson, A; Hüneburg, R; Kallenberg, FG; Kanth, P; Lalloo, F; Lim, R; Lynch, P; Roos, VH; Rustgi, AK; Samadder, NJ; Sinicrope, FA; Stoffel, EM; Strassburg, CP; Syngal, S; Van Cutsem, E; Weiss, JM; Willingham, FF; Wise, PE, 2020) |
| "Clinical familial adenomatous polyposis (FAP) syndrome represents a high risk pre-invasive precursor for colon cancer, and is characterized by germ line mutation in the adenomatous polyposis coli (APC) tumor suppressor gene." | 1.35 | Novel cell culture model for prevention of carcinogenic risk in familial adenomatous polyposis syndrome. ( Katdare, M; Telang, N, 2009) |
| "Celecoxib has shown benefit in regressing colorectal adenomas and appears to have some duodenal activity as well." | 1.35 | Chemoprevention with special reference to inherited colorectal cancer. ( Lynch, PM, 2008) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 4 (40.00) | 29.6817 |
| 2010's | 3 (30.00) | 24.3611 |
| 2020's | 3 (30.00) | 2.80 |
| Authors | Studies |
|---|---|
| Kemp Bohan, PM | 1 |
| Mankaney, G | 1 |
| Vreeland, TJ | 1 |
| Chick, RC | 1 |
| Hale, DF | 1 |
| Cindass, JL | 1 |
| Hickerson, AT | 1 |
| Ensley, DC | 1 |
| Sohn, V | 1 |
| Clifton, GT | 1 |
| Peoples, GE | 1 |
| Burke, CA | 4 |
| Dekker, E | 3 |
| Lynch, P | 1 |
| Samadder, NJ | 3 |
| Balaguer, F | 2 |
| Hüneburg, R | 2 |
| Burn, J | 1 |
| Castells, A | 1 |
| Gallinger, S | 1 |
| Lim, R | 1 |
| Stoffel, EM | 2 |
| Gupta, S | 1 |
| Henderson, A | 1 |
| Kallenberg, FG | 1 |
| Kanth, P | 1 |
| Roos, VH | 1 |
| Ginsberg, GG | 1 |
| Sinicrope, FA | 1 |
| Strassburg, CP | 1 |
| Van Cutsem, E | 2 |
| Church, J | 2 |
| Lalloo, F | 1 |
| Willingham, FF | 1 |
| Wise, PE | 2 |
| Grady, WM | 1 |
| Ford, M | 1 |
| Weiss, JM | 1 |
| Gryfe, R | 1 |
| Rustgi, AK | 1 |
| Syngal, S | 1 |
| Cohen, A | 3 |
| Lynch, PM | 3 |
| Lim, RM | 1 |
| Boytim, ML | 1 |
| Du, W | 1 |
| Bruckheimer, EM | 1 |
| Stoffel, E | 1 |
| Ignatenko, NA | 1 |
| Besselsen, DG | 1 |
| Stringer, DE | 1 |
| Blohm-Mangone, KA | 1 |
| Cui, H | 1 |
| Gerner, EW | 2 |
| Telang, N | 1 |
| Katdare, M | 1 |
| Rial, NS | 1 |
| Zell, JA | 1 |
| Cohen, AM | 1 |
| Benamouzig, R | 1 |
| Chaussade, S | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Phase III Trial of the Safety and Efficacy of Eflornithine Combined With Sulindac Compared to Eflornithine, Sulindac as Single Agents in Patients With Familial Adenomatous Polyposis[NCT01483144] | Phase 3 | 171 participants (Actual) | Interventional | 2013-10-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Global assessment of change in lower GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint. (NCT01483144)
Timeframe: through month 12 assessment
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Improved | Not Improved | |
| Eflornithine Plus Sulindac | 22 | 34 |
| Eflornithine Plus Sulindac Placebo | 16 | 41 |
| Sulindac Plus Eflornithine Placebo | 22 | 36 |
Global assessment of change in upper GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint. (NCT01483144)
Timeframe: through month 12 assessment
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Improved | Not Improved | |
| Eflornithine Plus Sulindac | 11 | 45 |
| Eflornithine Plus Sulindac Placebo | 10 | 47 |
| Sulindac Plus Eflornithine Placebo | 10 | 48 |
Progression of disease by evaluation of FAP-related events over the course of study treatment (NCT01483144)
Timeframe: Up to 48 months from the start of treatment
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Number with FAP-related events | Number with Lower GI FAP-related events | |
| Eflornithine Plus Sulindac | 18 | 2 |
| Eflornithine Plus Sulindac Placebo | 23 | 10 |
| Sulindac Plus Eflornithine Placebo | 22 | 9 |
4 reviews available for eflornithine and Adenomatous Polyposis Coli, Familial
| Article | Year |
|---|---|
Chemoprevention in familial adenomatous polyposis: past, present and future.
Topics: Adenomatous Polyposis Coli; Anti-Inflammatory Agents, Non-Steroidal; Antibiotics, Antineoplastic; As | 2021 |
Chemoprevention of familial adenomatous polyposis.
Topics: Adenomatous Polyposis Coli; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Aspirin; | 2016 |
Clinical end points for developing pharmaceuticals to manage patients with a sporadic or genetic risk of colorectal cancer.
Topics: Adenomatous Polyposis Coli; Antineoplastic Agents; Chemoprevention; Clinical Trials as Topic; Colono | 2012 |
[Chemoprevention of colorectal cancer].
Topics: Adenomatous Polyposis Coli; Animals; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; | 2002 |
3 trials available for eflornithine and Adenomatous Polyposis Coli, Familial
| Article | Year |
|---|---|
Eflornithine plus Sulindac for Prevention of Progression in Familial Adenomatous Polyposis.
Topics: Adenomatous Polyposis Coli; Adult; Disease Progression; Drug Therapy, Combination; Eflornithine; Fem | 2020 |
Combination of Sulindac and Eflornithine Delays the Need for Lower Gastrointestinal Surgery in Patients With Familial Adenomatous Polyposis: Post Hoc Analysis of a Randomized Clinical Trial.
Topics: Adenomatous Polyposis Coli; Adult; Disease Progression; Eflornithine; Humans; Proctocolectomy, Resto | 2022 |
Efficacy and safety of eflornithine (CPP-1X)/sulindac combination therapy versus each as monotherapy in patients with familial adenomatous polyposis (FAP): design and rationale of a randomized, double-blind, Phase III trial.
Topics: Adenomatous Polyposis Coli; Adult; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Proto | 2016 |
3 other studies available for eflornithine and Adenomatous Polyposis Coli, Familial
| Article | Year |
|---|---|
Combination chemoprevention of intestinal carcinogenesis in a murine model of familial adenomatous polyposis.
Topics: Adenoma; Adenomatous Polyposis Coli; Animals; Biogenic Polyamines; Celecoxib; Chemoprevention; Eflor | 2008 |
Novel cell culture model for prevention of carcinogenic risk in familial adenomatous polyposis syndrome.
Topics: Adenomatous Polyposis Coli; Animals; Anticarcinogenic Agents; Catechin; Cell Line; Colonic Neoplasms | 2009 |
Chemoprevention with special reference to inherited colorectal cancer.
Topics: Adenomatous Polyposis Coli; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Ascorbic | 2008 |