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NCT02916095
Evaluation Kanitinib Treatment of Recurrent or Metastatic Malignant Solid Tumors Safety, Tolerability and Pharmacokinetic Open, Dose Escalation Phase I Clinical Study
Phase 1 trial testing Kanitinib in Solid Tumors in 9 participants. Completed in 1 July 2020.
1 January 2020
Quick facts
| Lead sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 November 2016 |
| Primary completion | 1 January 2020 |
| Estimated completion | 1 July 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Kanitinib — full drug profile →
Conditions studied
- Solid Tumors — all drugs for Solid Tumors →
Sponsor
Beijing Konruns Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Adverse events accessment, changes of physical signs, laboratory examination and 12-lead electrocardiogram.
Time frame: 2 year
The safety and tolerability will be assessed according to NCI CTC AE V4.03, other safety indexes include adverse events, changes of physical signs, laboratory examination (hematology, blood biochemistry, urine routine, etc.) and a 12-lead electrocardiogram. -
Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Kanitinib in subjects with advanced solid tumors
Time frame: 2 year
Sponsor's own description
The purpose of this study is to evaluate the safety , tolerability, pharmacokinetics of Kanitinib and determine the optimal dose in patients with recurrent or metastatic solid tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02916095
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumors
Currently open trials in the same condition.
- NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
- NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
- NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting
Other Beijing Konruns Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06564272 — A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma · Phase 2 · recruiting
- NCT06194734 — A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer · Phase 3 · recruiting
- NCT05265338 — A Food Effect Study of KC1036 in Healthy Subjects · NA · completed
- NCT05260385 — To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors · Phase 1, PHASE2 · recruiting
- NCT05460546 — The Effect of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02916095 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Konruns Pharmaceutical Co., Ltd.
- Last refreshed: 1 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02916095.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing