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| Name | Class |
|---|---|
| Covance | INDUSTRY |
| XuanZhu Pharma Co., Ltd. | UNKNOWN |
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The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.
This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KBP-5209 | Experimental | Dose escalation for KBP-5209 will initially follow a modified accelerated titration design with a starting dose of 20 mg QD. Early dose escalation will proceed with one-patient cohorts and 100% dose increments (ie, dose doubling) until a patient experiences a DLT, at which point the cohorts will move to a 3+3 design. Treatment will continue until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons. A cycle is defined as continuous treatment for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KBP-5209 | Drug | Single oral dose beginning at 20 mg with daily dosing for 28 day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-dependency of toxicity based on: dose limiting toxicities; frequency, type, grade, and seriousness, and causality of treatment-emergent adverse events, and laboratory assessments. | While undergoing study treatment and up to 30 days after the last dose of KBP-5209 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7165009 | Background | Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available. | |
| 9262252 | Background | Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst. 1997 Aug 6;89(15):1138-47. doi: 10.1093/jnci/89.15.1138. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| University of Texas MD Anderson Cancer Center |
| Houston |
| Texas |
| 77030 |
| United States |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Background | Gibaldi M, Perrier D. Pharmacokinetics. 2nd edition. New York, NY: Marcel Dekker, Inc.; 1982. |
| Background | ICH E3: Guideline for Industry: Structure and Content of Clinical Study Reports. 1996. |
| 23680147 | Background | Jaiswal BS, Kljavin NM, Stawiski EW, Chan E, Parikh C, Durinck S, Chaudhuri S, Pujara K, Guillory J, Edgar KA, Janakiraman V, Scholz RP, Bowman KK, Lorenzo M, Li H, Wu J, Yuan W, Peters BA, Kan Z, Stinson J, Mak M, Modrusan Z, Eigenbrot C, Firestein R, Stern HM, Rajalingam K, Schaefer G, Merchant MA, Sliwkowski MX, de Sauvage FJ, Seshagiri S. Oncogenic ERBB3 mutations in human cancers. Cancer Cell. 2013 May 13;23(5):603-17. doi: 10.1016/j.ccr.2013.04.012. |
| 29954840 | Derived | Li M, Liu F, Zhang F, Zhou W, Jiang X, Yang Y, Qu K, Wang Y, Ma Q, Wang T, Bai L, Wang Z, Song X, Zhu Y, Yuan R, Gao Y, Liu Y, Jin Y, Li H, Xiang S, Ye Y, Zhang Y, Jiang L, Hu Y, Hao Y, Lu W, Chen S, Gu J, Zhou J, Gong W, Zhang Y, Wang X, Liu X, Liu C, Liu H, Liu Y, Liu Y. Genomic ERBB2/ERBB3 mutations promote PD-L1-mediated immune escape in gallbladder cancer: a whole-exome sequencing analysis. Gut. 2019 Jun;68(6):1024-1033. doi: 10.1136/gutjnl-2018-316039. Epub 2018 Jun 28. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |