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| ID | Type | Description | Link |
|---|---|---|---|
| I4D-MC-JTJI | Other Identifier | Eli Lilly and Company | |
| 2015-001215-12 | EudraCT Number |
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The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part.
The primary purpose of Parts A and B of this study is to determine a recommended dose level of prexasertib (an inhibitor of checkpoint kinase 1[Chk-1]) in combination with cisplatin and radiation therapy (Part A) or cetuximab and radiation therapy (Part B) in participants with locally advanced head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prexasertib + Cisplatin + Radiation Therapy (Part A) | Experimental | Prexasertib administered intravenously (IV) every 14 days over an approximately 49-day treatment period. Cisplatin administered IV every 7 days over an approximately 49-day treatment period. Intensity modulated radiation therapy administered 5 days per week over an approximately 49-day treatment period. Participants may remain on treatment until completion of the treatment period. |
|
| Prexasertib + Cetuximab + Radiation Therapy (Part B) | Experimental | Prexasertib administered IV every 14 days over an approximately 56-day treatment period. Cetuximab administered IV every 7 days over an approximately 56-day treatment period. Intensity modulated radiation therapy administered 5 days per week over an approximately 56-day treatment period (starting at Week 2). Participants may remain on treatment until completion of the treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prexasertib | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy | First Dose through Last Dose (Estimated up to 7 Weeks) | |
| Part B: Maximum Tolerated Dose of Prexasertib in Combination with Cetuximab and Radiation Therapy | First Dose through Last Dose (Estimated up to 8 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab | First Dose through Last Dose (Estimated up to 8 Weeks) | |
| PK: Area Under the Concentration Curve (AUC) of Prexasertib | First Dose through Last Dose (Estimated up to 8 Weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35249 | United States | ||
| University of Texas MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32371584 | Derived | Zeng L, Nikolaev A, Xing C, Della Manna DL, Yang ES. CHK1/2 Inhibitor Prexasertib Suppresses NOTCH Signaling and Enhances Cytotoxicity of Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2020 Jun;19(6):1279-1288. doi: 10.1158/1535-7163.MCT-19-0946. Epub 2020 May 5. | |
| 28138028 | Derived |
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| Cisplatin | Drug | Administered IV |
|
| Cetuximab | Drug | Administered IV |
|
|
| Intensity Modulated Radiation Therapy | Radiation |
|
| Locoregional Control Rate | Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause |
| Houston |
| Texas |
| 77030 |
| United States |
| Centre Leon Berard | Lyon | 69008 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Zeng L, Beggs RR, Cooper TS, Weaver AN, Yang ES. Combining Chk1/2 Inhibition with Cetuximab and Radiation Enhances In Vitro and In Vivo Cytotoxicity in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2017 Apr;16(4):591-600. doi: 10.1158/1535-7163.MCT-16-0352. Epub 2017 Jan 30. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000608121 | prexasertib |
| D002945 | Cisplatin |
| D000068818 | Cetuximab |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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