Phase 1b, multicenter, single blinded, placebo‐controlled, sequential dose escalation study to assess the safety and tolerability of topically applied AG013 in subjects with locally advanced head and neck cancer receiving induction chemotherapy
BACKGROUND Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluat...
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| Veröffentlicht in: | Cancer Jg. 119; H. 24; S. 4268 - 4276 |
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| Hauptverfasser: | , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
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Hoboken, NJ
Wiley-Blackwell
15.12.2013
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| ISSN: | 0008-543X, 1097-0142, 1097-0142 |
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| Abstract | BACKGROUND
Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluated in a phase 1b study in LAHNC subjects who received induction with cisplatin, 5‐fluorouracil, with or without docetaxel. Preliminary efficacy data were also obtained.
METHODS
A total of 25 of 52 LAHNC subjects who were followed during induction cycle 1 developed ulcerative oral mucositis (UOM; World Health Organization grade > 2) and were randomized to AG013:placebo (5:2 ratio) for cycle 2. Dosing schedules of 1, 3, or 6 times daily were evaluated (2 × 1011, 6 × 1011, and 1.2 × 1012 colony forming units per day, respectively). OM was evaluated daily from cycle 2, day 1 through 14, using World Health Organization criteria. Pharmacokinetic assessment was also conducted.
RESULTS
AG013 bacteria were not detected in blood. Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Efficacy analysis showed a 35% reduction in percentage of days with UOM in AG013‐subjects versus placebo. All placebo subjects experienced ≥ 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.
CONCLUSIONS
AG013 was safe and well tolerated. Preliminary efficacy data support further study. Cancer 2013;119:4268–4276. © 2013 American Cancer Society.
An oral rinse formulation of AG013 containing recombinant Lactococcus lactis secreting the mucosal protectant human Trefoil Factor 1 (hTFF1) was evaluated in a phase 1b study in subjects with locally advanced head and neck cancer who were receiving induction chemotherapy with cisplatin, 5‐fluorouracil with or without docetaxel. AG013 rinse was found to be safe and tolerable with preliminary efficacy data warranting further study. |
|---|---|
| AbstractList | Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluated in a phase 1b study in LAHNC subjects who received induction with cisplatin, 5-fluorouracil, with or without docetaxel. Preliminary efficacy data were also obtained.
A total of 25 of 52 LAHNC subjects who were followed during induction cycle 1 developed ulcerative oral mucositis (UOM; World Health Organization grade > 2) and were randomized to AG013:placebo (5:2 ratio) for cycle 2. Dosing schedules of 1, 3, or 6 times daily were evaluated (2 × 10(11) , 6 × 10(11) , and 1.2 × 10(12) colony forming units per day, respectively). OM was evaluated daily from cycle 2, day 1 through 14, using World Health Organization criteria. Pharmacokinetic assessment was also conducted.
AG013 bacteria were not detected in blood. Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Efficacy analysis showed a 35% reduction in percentage of days with UOM in AG013-subjects versus placebo. All placebo subjects experienced ≥ 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.
AG013 was safe and well tolerated. Preliminary efficacy data support further study. An oral rinse formulation of AG013 containing recombinant Lactococcus lactis secreting the mucosal protectant human Trefoil Factor 1 (hTFF1) was evaluated in a phase 1b study in subjects with locally advanced head and neck cancer who were receiving induction chemotherapy with cisplatin, 5‐fluorouracil with or without docetaxel. AG013 rinse was found to be safe and tolerable with preliminary efficacy data warranting further study. BACKGROUND Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluated in a phase 1b study in LAHNC subjects who received induction with cisplatin, 5‐fluorouracil, with or without docetaxel. Preliminary efficacy data were also obtained. METHODS A total of 25 of 52 LAHNC subjects who were followed during induction cycle 1 developed ulcerative oral mucositis (UOM; World Health Organization grade > 2) and were randomized to AG013:placebo (5:2 ratio) for cycle 2. Dosing schedules of 1, 3, or 6 times daily were evaluated (2 × 1011, 6 × 1011, and 1.2 × 1012 colony forming units per day, respectively). OM was evaluated daily from cycle 2, day 1 through 14, using World Health Organization criteria. Pharmacokinetic assessment was also conducted. RESULTS AG013 bacteria were not detected in blood. Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Efficacy analysis showed a 35% reduction in percentage of days with UOM in AG013‐subjects versus placebo. All placebo subjects experienced ≥ 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement. CONCLUSIONS AG013 was safe and well tolerated. Preliminary efficacy data support further study. Cancer 2013;119:4268–4276. © 2013 American Cancer Society. An oral rinse formulation of AG013 containing recombinant Lactococcus lactis secreting the mucosal protectant human Trefoil Factor 1 (hTFF1) was evaluated in a phase 1b study in subjects with locally advanced head and neck cancer who were receiving induction chemotherapy with cisplatin, 5‐fluorouracil with or without docetaxel. AG013 rinse was found to be safe and tolerable with preliminary efficacy data warranting further study. Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluated in a phase 1b study in LAHNC subjects who received induction with cisplatin, 5-fluorouracil, with or without docetaxel. Preliminary efficacy data were also obtained.BACKGROUNDOral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluated in a phase 1b study in LAHNC subjects who received induction with cisplatin, 5-fluorouracil, with or without docetaxel. Preliminary efficacy data were also obtained.A total of 25 of 52 LAHNC subjects who were followed during induction cycle 1 developed ulcerative oral mucositis (UOM; World Health Organization grade > 2) and were randomized to AG013:placebo (5:2 ratio) for cycle 2. Dosing schedules of 1, 3, or 6 times daily were evaluated (2 × 10(11) , 6 × 10(11) , and 1.2 × 10(12) colony forming units per day, respectively). OM was evaluated daily from cycle 2, day 1 through 14, using World Health Organization criteria. Pharmacokinetic assessment was also conducted.METHODSA total of 25 of 52 LAHNC subjects who were followed during induction cycle 1 developed ulcerative oral mucositis (UOM; World Health Organization grade > 2) and were randomized to AG013:placebo (5:2 ratio) for cycle 2. Dosing schedules of 1, 3, or 6 times daily were evaluated (2 × 10(11) , 6 × 10(11) , and 1.2 × 10(12) colony forming units per day, respectively). OM was evaluated daily from cycle 2, day 1 through 14, using World Health Organization criteria. Pharmacokinetic assessment was also conducted.AG013 bacteria were not detected in blood. Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Efficacy analysis showed a 35% reduction in percentage of days with UOM in AG013-subjects versus placebo. All placebo subjects experienced ≥ 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.RESULTSAG013 bacteria were not detected in blood. Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Efficacy analysis showed a 35% reduction in percentage of days with UOM in AG013-subjects versus placebo. All placebo subjects experienced ≥ 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.AG013 was safe and well tolerated. Preliminary efficacy data support further study.CONCLUSIONSAG013 was safe and well tolerated. Preliminary efficacy data support further study. |
| Author | Cilli, Fiona Haddad, Robert I. Limaye, Sewanti Atul Brennan, Michael T. Colevas, A. Dimitrios Murphy, Barbara A. Sonis, Stephen T. Hu, Kenneth S. |
| Author_xml | – sequence: 1 givenname: Sewanti Atul surname: Limaye fullname: Limaye, Sewanti Atul organization: Dana‐Farber Cancer Institute/Harvard Medical School – sequence: 2 givenname: Robert I. surname: Haddad fullname: Haddad, Robert I. organization: Dana‐Farber Cancer Institute/Harvard Medical School – sequence: 3 givenname: Fiona surname: Cilli fullname: Cilli, Fiona organization: ActoGeniX NV – sequence: 4 givenname: Stephen T. surname: Sonis fullname: Sonis, Stephen T. organization: Biomodels LLC – sequence: 5 givenname: A. Dimitrios surname: Colevas fullname: Colevas, A. Dimitrios organization: Stanford University – sequence: 6 givenname: Michael T. surname: Brennan fullname: Brennan, Michael T. organization: Carolinas Medical Center – sequence: 7 givenname: Kenneth S. surname: Hu fullname: Hu, Kenneth S. organization: Beth Israel Medical Center – sequence: 8 givenname: Barbara A. surname: Murphy fullname: Murphy, Barbara A. organization: Vanderbilt University Medical Center |
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| Keywords | Human oral mucositis Stomatology Toxicity Multicenter study Single dose Malignant tumor Induction treatment safety and tolerability Increasing dose Stomatitis mouth rinse Cancerology Sequential Placebo ENT disease Head and neck cancer Oral cavity disease Locally advanced stage induction chemotherapy Cancer head and neck cancer |
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| References_xml | – volume: 349 start-page: 2091 year: 2003 end-page: 2098 article-title: Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer publication-title: N Engl J Med – volume: 27 start-page: 4333 year: 2009 end-page: 4338 article-title: Phase II, randomized, double‐blind, placebo‐controlled study of recombinant human intestinal trefoil factor oral spray for prevention of oral mucositis in patients with colorectal cancer who are receiving fluorouracil‐based chemotherapy publication-title: J Clin Oncol – volume: 289 start-page: 1352 year: 2000 end-page: 1355 article-title: Treatment of murine colitis by Lactococcus lactis secreting interleukin‐10 publication-title: Science – volume: 4 start-page: 754 year: 2006 end-page: 759 article-title: A phase I trial with transgenic bacteria expressing interleukin‐10 in Crohn's disease publication-title: Clin Gastroenterol Hepatol – volume: 21 start-page: 785 year: 2003 end-page: 789 article-title: Biological containment of genetically modified Lactococcus lactis for intestinal delivery of human interleukin 10 publication-title: Nat Biotechnol – volume: 25 start-page: 727 year: 2004 end-page: 730 article-title: Trefoil factor family (TFF) peptides: regulators of mucosal regeneration and repair, and more publication-title: Peptides – volume: 127 start-page: 502 year: 2004 end-page: 513 article-title: Active delivery of trefoil factors by genetically modified Lactococcus lactis prevents and heals acute colitis in mice publication-title: Gastroenterology – volume: 24 start-page: 5194 year: 2006 end-page: 5200 article-title: Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil‐based chemotherapy publication-title: J Clin Oncol – volume: 357 start-page: 1705 year: 2007 end-page: 1715 article-title: Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer publication-title: N Engl J Med – volume: 109 start-page: 820 year: 2007 end-page: 831 article-title: Updated clinical practice guidelines for the prevention and treatment of mucositis publication-title: Cancer – volume: 357 start-page: 1695 year: 2007 end-page: 1704 article-title: Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer publication-title: N Engl J Med – volume: 46 start-page: 564 year: 2010 end-page: 570 article-title: AG013, a mouth rinse formulation of Lactococcus lactis secreting human Trefoil Factor 1, provides a safe and efficacious therapeutic tool for treating oral mucositis publication-title: Oral Oncol – volume: 115 start-page: 91 year: 2003 end-page: 99 article-title: Injected TFF1 and TFF3 bind to TFF2‐immunoreactive cells in the gastrointestinal tract in rats publication-title: Regul Pept – volume: 24 start-page: 5186 year: 2006 end-page: 5193 article-title: Palifermin reduces patient‐reported mouth and throat soreness and improves patient functioning in the hematopoietic stem‐cell transplantation setting publication-title: J Clin Oncol – volume: 4 start-page: 721 year: 2003 end-page: 732 article-title: Trefoil factors: initiators of mucosal healing publication-title: Nat Rev Mol Cell Biol – volume: 31 start-page: 509 year: 2000 end-page: 515 article-title: Trefoil factor expression in normal and diseased human salivary glands publication-title: Hum Pathol – volume: 126 start-page: 796 year: 2004 end-page: 808 article-title: Chemotherapy‐ and radiotherapy‐induced intestinal damage is regulated by intestinal trefoil factor publication-title: Gastroenterology – year: 2013 – year: 2012 – ident: e_1_2_7_4_1 doi: 10.1056/NEJMoa071028 – ident: e_1_2_7_12_1 doi: 10.1126/science.289.5483.1352 – ident: e_1_2_7_10_1 doi: 10.1053/j.gastro.2003.12.004 – ident: e_1_2_7_13_1 doi: 10.1038/nbt840 – ident: e_1_2_7_8_1 doi: 10.1038/nrm1203 – ident: e_1_2_7_14_1 doi: 10.1053/j.gastro.2004.05.020 – ident: e_1_2_7_5_1 doi: 10.1200/JCO.2005.04.1152 – ident: e_1_2_7_16_1 doi: 10.1056/NEJMoa031317 – ident: e_1_2_7_15_1 doi: 10.1016/j.oraloncology.2010.04.008 – ident: e_1_2_7_9_1 doi: 10.1053/hp.2000.6549 – ident: e_1_2_7_17_1 doi: 10.1016/j.cgh.2006.03.028 – ident: e_1_2_7_18_1 – ident: e_1_2_7_6_1 doi: 10.1016/j.peptides.2004.03.019 – volume-title: ActoGeniX announces positive results from a phase 1 PK study of AG013 for the prevention of oral mucositis in cancer patients [press release] year: 2012 ident: e_1_2_7_20_1 – ident: e_1_2_7_3_1 doi: 10.1056/NEJMoa070956 – ident: e_1_2_7_2_1 doi: 10.1002/cncr.22484 – ident: e_1_2_7_19_1 doi: 10.1200/JCO.2005.02.8340 – ident: e_1_2_7_11_1 doi: 10.1200/JCO.2008.21.2381 – ident: e_1_2_7_7_1 doi: 10.1016/S0167-0115(03)00145-9 |
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Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and... An oral rinse formulation of AG013 containing recombinant Lactococcus lactis secreting the mucosal protectant human Trefoil Factor 1 (hTFF1) was evaluated in a... Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of... |
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| SubjectTerms | Administration, Topical Adolescent Adult Aged Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Biological and medical sciences Female head and neck cancer Head and Neck Neoplasms - drug therapy Head and Neck Neoplasms - metabolism Head and Neck Neoplasms - microbiology Humans Induction Chemotherapy Lactococcus lactis - genetics Lactococcus lactis - metabolism Male Medical sciences Middle Aged Mouth Mucosa - drug effects Mouth Mucosa - microbiology mouth rinse Mouthwashes - administration & dosage Mouthwashes - adverse effects Multiple tumors. Solid tumors. Tumors in childhood (general aspects) oral mucositis Otorhinolaryngology (head neck, general aspects and miscellaneous) Otorhinolaryngology. Stomatology safety and tolerability Stomatitis - chemically induced Stomatitis - drug therapy Stomatitis - microbiology Stomatitis - prevention & control Trefoil Factor-1 Tumor Suppressor Proteins - administration & dosage Tumor Suppressor Proteins - biosynthesis Tumor Suppressor Proteins - pharmacokinetics Tumors Young Adult |
| Title | Phase 1b, multicenter, single blinded, placebo‐controlled, sequential dose escalation study to assess the safety and tolerability of topically applied AG013 in subjects with locally advanced head and neck cancer receiving induction chemotherapy |
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