Kanitinib in Treating Patients With Advanced Solid Tumors

NCT02916095 | Completed Phase 1

• 1 other identifier: KNTN-I-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  2 year

• Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Kanitinib in subjects with advanced solid tumors

  2 year

Study Arms (1)

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.

Drug: Kanitinib

Interventions

Kanitinib DRUG

Oral administration of Kanitinib tablets.

Also known as: CX1003

Kanitinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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)

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Officials

• Yuankai Shi, Dr

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 27, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)