Solid TumorsPhase 1NCT02916095
Kanitinib in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing Kanitinib in people with Solid Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Kanitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 65 years old, both genders
- patients (recruited in dose-escalation stage and dose-expansion stage) with recurrent or metastatic solid tumors are confirmed by histology staining. medullary thyroid carcinoma, radioactive iodine resistant differentiated thyroid cancers, renal cell carcinomas, lung cancers, liver cancers, gastric cancers and prostate cancers are priority selections.
- Patients are not response to standard therapy or not able to tolerate standard therapy.
- Have measurable tumor lesion (evaluated by RECIST1.1 criteria.)
- Vital organs without seriously abnormality
- With Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time estimated to be at least 12 weeks
- Competent to comprehend, sign, and date an approved informed consent form
Who cannot join
- Absolute neutrophil count (ANC) < 1.5 x 109 / L or platelet < 100 x 109 / L or hemoglobin < 9 g/dL (refer to the normal reference range in clinical trial center).
- Total bilirubin > 1.5×the upper limit of normal range (ULN).
- Aspartate aminotransferase （AST）and/or Alanine transaminase（ALT）and/or Alkaline phosphatase(ALP) >1.5xULN without liver metastases ; AST and/or ALT and/or ALP levels ≥5xULN with liver metastases .
- Serum creatinine >1.5xULN.
- The porthrombin international normalized ratio (INR)and activated partial thromboplastin time (aPPT) >1.5xULN
- Receive chemotherapy (within 2 weeks with short half-time TKIs reagents), hormonal therapy,radiation therapy, biologics therapy or immunotherapy (within 6 weeks with nitrosoureas or mitomycin) 4 weeks prior to enrolment, except for:
Show all 25Show fewer
- Gonadotrophin releasing hormone (GnRH) therapy for prostate cancer
- Hormone-replacement therapy or oral contraceptives
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia.
- Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation therapy, or Brain metastases or spinal cord compression received treatments but without image evidence of showing stability ≥ 14 days.
- prior or presence of other malignancies ,with the exception of previously treated stage I B or lower grade cervical cancer， noninvasive basal cell or squamous cell cancer, breast cancer with complete remission (CR) > 10 years ,melanoma with CR > 10 years or other malignant tumors with CR > 5 years.
- Any of the following gastrointestinal disease:
- Active gastric and duodenal ulcer or intestinal obstruction;
- History of abdominal fistula, gastrointestinal perforation or abdominal abscess, or active digestive tract bleeding.
- Presence of hemorrhage (hemoptysis) or thrombosis disease，or currently receiving treatment with warfarin, aspirin, low molecular weight heparin (LMWH), or any other anti-platelet drugs(low dose of above mentioned drugs for prophylaxis are allowed)
- History of nephrotic syndrome.
- Patients with active infection, mental disorders or other serious nonmalignant diseases, such as congestive heart failure or unstable angina within 3 months prior to study entry, myocardial infarction or stroke within six months prior to study entry, serious arrhythmia; or those who receive therapeutical dose of anti-hypertension drugs with systolic blood pressure ≥160 mmHg or diastolic blood pressure≥100 mmHg （measured at least twice）.
- Receive surgery(including minimally invasive biopsy, open biopsy or major injuries) within 30 days, or unhealed surgical incision, ulcer , fractures, tooth extraction or other dental surgery with open wounds.
- Inability to take oral medication, prior surgical procedures or serious gastrointestinal disorders such as dysphagia and other disease that may affect drug absorption in the opinion of the investigator.
- With clinical significance of liver disease history, including viral or other hepatitis , or cirrhosis.
- Known human immunodeficiency virus infection.
- Pregnant or lactating women or those who do not take contraceptives, including men.
- Inability to comply with study and follow-up procedures
- Involved in other clinical trials < 30 days prior to enrollment.
- Any other diseases, metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings. According to investigators' judgment, patients has certain diseases or conditions are not suitable for using study drug, or affect the interpretation of the results of study, or high risk patients
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Evaluation Kanitinib Treatment of Recurrent or Metastatic Malignant Solid Tumors Safety, Tolerability and Pharmacokinetic Open, Dose Escalation Phase I Clinical Study
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.
Read the detailed description
Evaluation of recurrent or metastatic solid tumor patients on Kanitinib single dose and continuous multiple dose safety and tolerability, and to determine the maximum tolerated Connie imatinib dose (MTD) or the phase II trial recommended dosage.
- Conditions
- Solid Tumors
- Being tested
- Kanitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KanitinibDrug
Also called CX1003
Oral administration of Kanitinib tablets.
| Study group | Role | What they receive |
|---|---|---|
| Kanitinib | Experimental | Subjects will be enrolled in cohorts at different dose levels in order to evaluate the safety,tolerability and determine the maximum tolerated dose and recommended phase II dose of kanitinib. Receives: Drug: Kanitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events accessment, changes of physical signs, laboratory examination and 12-lead electrocardiogram.
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.
Measured: 2 year
Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Kanitinib in subjects with advanced solid tumors
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Dr, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916095
- Sponsor's protocol ID
- KNTN-I-01
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2016
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Kanitinib Treatment of Recurrent or Metastatic Malignant Solid Tumors Safety, Tolerability and Pharmacokinetic Open, Dose Escalation Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT02916095
- Acronym / sponsor ID
- KNTN-I-01
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evaluation of recurrent or metastatic solid tumor patients on Kanitinib single dose and continuous multiple dose safety and tolerability, and to determine the maximum tolerated Connie imatinib dose (MTD) or the phase II trial recommended dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kanitinib | Experimental | Drug: KanitinibSubjects will be enrolled in cohorts at different dose levels in order to evaluate the safety,tolerability and determine the maximum tolerated dose and recommended phase II dose of kanitinib. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years to 65 years old, both genders
- patients (recruited in dose-escalation stage and dose-expansion stage) with recurrent or metastatic solid tumors are confirmed by histology staining. medullary thyroid carcinoma, radioactive iodine resistant differentiated thyroid cancers, renal cell carcinomas, lung cancers, liver cancers, gastric cancers and prostate cancers are priority selections.
- Patients are not response to standard therapy or not able to tolerate standard therapy.
- Have measurable tumor lesion (evaluated by RECIST1.1 criteria.)
- Vital organs without seriously abnormality
Key exclusion criteria (25 listed)
- Absolute neutrophil count (ANC) < 1.5 x 109 / L or platelet < 100 x 109 / L or hemoglobin < 9 g/dL (refer to the normal reference range in clinical trial center).
- Total bilirubin > 1.5×the upper limit of normal range (ULN).
- Aspartate aminotransferase （AST）and/or Alanine transaminase（ALT）and/or Alkaline phosphatase(ALP) >1.5xULN without liver metastases ; AST and/or ALT and/or ALP levels ≥5xULN with liver metastases .
- Serum creatinine >1.5xULN.
- The porthrombin international normalized ratio (INR)and activated partial thromboplastin time (aPPT) >1.5xULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KanitinibAlso: CX1003Oral administration of Kanitinib tablets. | Drug | Kanitinib |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
Active, not recruitingPhase 1
Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
Solid Tumors
RecruitingObservational study
Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Malignant Solid Tumors, Other Neoplasms Solid Tumors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, Dr principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kanitinib in people with Solid Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events accessment, changes of physical signs, laboratory examination and 12-lead electrocardiogram. (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.