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The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chiauranib administered orally over a range of doses in patients with advanced solid tumors.
The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests ,etc., of a range of doses of Chiauranib in solid tumor patients, and to determine the dose limit toxicity and the maximum tolerable dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiauranib | Experimental | Patients take a single dose of Chiauranib capsules for the pharmacokinetic study,then off for 5 days before the first cycle begins. In the subsequent treatment cycles, Chiauranib capsules are given orally once daily, 28 days as a cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiauranib | Drug | Take orally |
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| Measure | Description | Time Frame |
|---|---|---|
| dose-limiting toxicity (DLT) | day 1-28 | |
| Number of Adverse Events | An expected average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic profile of Chiauranib | On day 1,8,15,22,25,26,27,28 | |
| Evidence of benefit | clinical benefit rate (complete response (CR),partial response (PR),stable disease (SD) > 8 weeks),duration of response (DOR),time to progression (TTP), or tumor marker improvement, if appropriate |
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Inclusion Criteria:
Histological or cytological confirmation of advanced solid tumor, including non-small cell lung cancer, colorectal cancer, ovarian cancer, renal cell carcinoma, gastrointestinal stromal tumor, gastric cancer, et al;
Patients with advanced solid tumors refractory to standard therapy or for which no standard therapy exists;
Body mass index (BMI) is between 18 and 28;
Age: 18~65 years;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Laboratory criteria are as follows:
Women of child-bearing potential should be non-lactating patients, and must agree to use effective contraceptive methods prior to study entry, during study participation, and up to 6 months following completion of therapy. A serum or urine pregnancy test within 7 days before enrollment must be negative; Men must agree to use effective contraceptive methods during study participation and up to 6 months following completion of therapy;
Willingness to sign a written informed consent document
Exclusion Criteria:
Life expectation < 3 months;
Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy and endocrine therapy, et al) within 4 weeks prior to study entry; Subjects received nitrosoureas or mitomycin chemotherapy within 6 weeks prior to study entry;
Have uncontrolled or significant cardiovascular disease, including:
Have active bleeding , current thrombotic disease, or patients with bleeding potential receiving anticoagulation therapy;
History of deep vein thrombosis or pulmonary embolism;
Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion,transportation or absorption of oral agents, or patients undergone gastrectomy;
Have symptomatic brain metastasis;
History of organ transplantation;
Proteinuria positive;
Congenital or acquired immunodeficiency, active infections;
Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
Any other condition which is inappropriate for the study in the opinion of the investigators.
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30642372 | Derived | Sun Y, Yang L, Hao X, Liu Y, Zhang J, Ning Z, Shi Y. Phase I dose-escalation study of chiauranib, a novel angiogenic, mitotic, and chronic inflammation inhibitor, in patients with advanced solid tumors. J Hematol Oncol. 2019 Jan 14;12(1):9. doi: 10.1186/s13045-018-0695-0. |
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| ID | Term |
|---|---|
| C000705608 | chiauranib |
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| An expected average of 8 months |
| Pharmacodynamic profile of Chiauranib | Plasma biomarkers: soluble vascular endothelial growth factor receptors (sVEGFR2), vascular endothelial growth factor (VEGF) Tumor tissue biomarkers: Aurora B, phospho-histone H3 | On day 15,28 |