Study of Chiauranib in Relapsed/Refractory Non-Hodgkin's Lymphoma

NCT03074825 | Terminated Phase 1

• 1 other identifier: CAR103
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora B）、VEGFR/PDGFR/c-Kit、CSF-1R targets. This clinical trial is studying the efficacy and safety of chiauranib works in treating patients with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.

Conditions

Non-Hodgkin's Lymphoma

Keywords

Non-Hodgkin's lymphoma; Relapsed/Refractory; Aurora kinase B

Outcome Measures

Primary Outcomes (1)

• Overall response rate(ORR)

  ORR will be calculated from the data obtained from the end visit

  assessed up to 2 years

Secondary Outcomes (6)

• Number of participants with treatment-related adverse events

  Measured through 2 years

• progression-free survival (PFS)

  assessed up to 2 years

• time to progression(TTP)

  through treatment completion, up to 2 years

• complete remission rate(CRR)

  through treatment completion, up to 2 years

• duration of response (DOR)

  assessed up to 2 years

Other Outcomes (3)

• immunohistochemical(IHC) staining results of Aurora B、CSF-1R and Myc protein

  assessed up to 2 years

• Any single mutation of oncogene and copy number variation in ctDNA(single gene analysis)

  assessed up to 2 years

• Mutation of polygene and copy number variation in signal pathway(multi-gene analysis)

  assessed up to 2 years

Study Arms (1)

chiauranib

EXPERIMENTAL

Patients take Chiauranib capsules 50mg, orally once daily, 28 days as a cycle.

Drug: Chiauranib

Interventions

Chiauranib DRUG

Take 50mg orally once daily

Also known as: CS2164

chiauranib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, aged ≥ 18 yrs and ≤70 yrs;
• Histological or cytological confirmation of non-Hodgkin's lymphoma（NHL）, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and other aggressive NHLs which determined by the investigator.
• Patients with NHL refractory to at least 2 different chemotherapies , for which no standard therapy exists;
• At least 1 lesion can be accurately measured, as defined by Lugano 2014 criteria.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should beyond 4 weeks prior to study entry; Subjects received mitomycin chemotherapy should beyond 6 weeks prior to study entry; Subjects received autologous stem cell transplantation should beyond 3 months prior to study entry;
• Laboratory criteria are as follows:
• Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets \>=90×109/L Biochemistry test: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦1.5×ULN; (ALT,AST≦5×ULN if liver involved) ;serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) \< 1.5
• Life expectancy of at least 12 weeks.
• Willingness to sign a written informed consent document.

You may not qualify if:

• Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years;
• Clinical evidence of central nervous system involvement;
• Have uncontrolled or significant cardiovascular disease, including:
• Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) \< 50% requiring treatment with agents during screening stage.
• primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
• History of significant QT interval prolongation, or Corrected QT Interval (QTc) \> 450 ms prior to study entry
• Symptomatic coronary heart disease requiring treatment with agents
• Uncontrolled hypertension (\> 140/90 mmHg) by single agent;
• Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
• Proteinuria positive(≥1g/24h);
• 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;
• History of organ transplantation or Allogeneic bone marrow transplantation;
• Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening (excluding placement of vascular access or biopsy) that involved general anaesthesia or respiratory assistance;

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence; Hereditary Sensory and Autonomic Neuropathies

Interventions

chiauranib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

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: March 1, 2017
• First Posted: March 9, 2017
• Study Start: May 9, 2017
• Primary Completion: August 15, 2017
• Study Completion: February 14, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

CN (1)