Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors

NCT03792958 | Unknown Phase 1

• 1 other identifier: CM082-CA-I-105
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Dosing of CM082 tablets in Chinese Patients With Advanced Malignant Solid Tumors

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (8)

• Maximum tolerable dose (MTD) or dose to absorb saturation

  From the first dose to the 28th day of administration

• Dose-Limiting Toxicity

  Characteristics of dose-limiting toxicity (DLT), evaluation criteria: National Cancer Institute (NCI) CTC classification (version 4.03)

  From the first dose to the 28th day of administration

• Pharmacokinetic parameters

  Peak concentration

  From the first dose to the 28th day of administration

• Pharmacokinetic parameters

  Area under the time curve of blood concentration from 0 h to the last time of blood collection

  From the first dose to the 28th day of administration

• Pharmacokinetic parameters

  0 to Infinite Area under Blood Drug Concentration Curve

  From the first dose to the 28th day of administration

• Pharmacokinetic parameters

  Peak time

  From the first dose to the 28th day of administration

• Pharmacokinetic parameters

  Apparent terminal elimination half-life

  From the first dose to the 28th day of administration

• Pharmacokinetic parameters

  Terminal elimination rate constant

  From the first dose to the 28th day of administration

Secondary Outcomes (4)

• Objective response rate

  12 months

• Disease control rate

  12 months

• Progression-free survival

  12 months

• Overall survival

  36 months

Study Arms (1)

CM082

EXPERIMENTAL

CM082 tablet

Drug: CM082

Interventions

CM082 DRUG

CM082 tablets taken orally 200、400、600 and 800 mg (QD or BID)

Also known as: X-82

CM082

Eligibility Criteria

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

You may qualify if:

• Age:≥18 years.
• BMI generally ranges from 18-28 (BMI=Weight (Kg)/Height (m)2)
• Patients with advanced malignant solid tumors confirmed by histological or cytological examination.
• According to Recist1.1 criteria, patients have measurable or assessable tumors, and patients with advanced malignant solid tumors who have failed to respond to previous standard treatment regimens, are unable to tolerate previous treatment regimens or lack effective treatment regimens.
• Organ function level must meet the following requirements (7 days before treatment):
• Bone marrow: absolute neutrophil count (ANC)≥1.5\^109/L, platelet (PLT)≥100\^109/L, hemoglobin (HB)≥9g/dL (no blood transfusion or component blood received within 14 days before detection).
• Liver: Serum bilirubin (TBIL) ≤1.5 \* upper limit of normal (ULN) , aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 \* ULN (If the patient's liver metastases, AST and ALT are allowed to be ≤ 5 \* ULN) ).
• Serum creatinine≤1.5 \* ULN and endogenous creatinine clearance rate≥50mL/min. According to Cockcroft-Gault formula, Please refer to attachment 7 for details.
• International normalized ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 \* ULN (This provision applies only to patients who do not receive anticoagulant treatment; for patients receiving anticoagulant treatment, anticoagulants should be used within the treatment requirements).
• Urine protein (UP)≤1+. If UP\>1+, 24-hour UP should be collected for determination, and the total amount of UP should be ≤1g.
• FT3、FT4 and thyroid-stimulating hormone (TSH) are normal or abnormal without clinical significance（Except for advanced thyroid cancer）.
• No immunodeficiency.
• The damage causes by other treatments is restored to 1 grade (CTCAE version 4.03), except for hair loss and pigmentation; If the nutritional status is stable, the long-term toxicity that cannot be recovered is allowed to exist by the investigator'judgement.
• Expected survival time≥ 3 months.
• Eastern Cooperative Group (ECOG) Performance Status score of ≤1.

You may not qualify if:

• Within 4 weeks before the first use of the study drug, the patient received anti- tumor drug therapy such as chemotherapy, targeted therapy, radiotherapy, biological therapy or endocrine therapy, except for the following: Nitrous urea or mitomycin C were used within 6 weeks before the first use of the study drug; Oral fluorouracil and small molecular targeted drugs were used within 2 weeks before the first use of the study drug or within 5 half-lives (whichever is the longer); Chinese medicine with anti-cancer indications was used within 1 week before the first use of the study drug.
• Surgical treatment (except biopsy) was performed within 4 weeks before the first use of study drug.
• Patients who have participated in or are participating in any other drug/therapy clinical trial (including but not limited to the anti-tumor clinical trial) within 4 weeks before treatment, counting from the time of last administration of the last clinical trial.
• Patients who received hematopoietic stimulating factors (e.g., granulocyte colony stimulating factor (G-CSF), erythropoietin, etc.) within one week before treatment.
• Pleural or ascites with clinical symptoms and requiring symptomatic treatment.
• Patients with active pulmonary disease, interstitial pneumonia or pulmonary fibrosis.
• Having any uncontrollable clinical problems or associated risk factors, including but not limited to:
• Poorly controlled hypertension (blood pressure persistently greater than 150/90 mmHg).
• Left ventricular ejection fraction (LVEF)≤50%.
• The QT interval of heart rate correction (QTc) \> 450 msec (males) or 460 msec (females) ( Bazett's correction (QTcB)=QT/(RR\^0.5)).
• Patients implanted with cardiac defibrillator.
• Poorly controlled diabetes \[(fasting blood glucose should not be greater than 8.9 mmol/L after drug control) refer to CTCAE version 4.03-grade 1 of hyperglycemia\].
• Heart disease (Class III/IV congestive heart failure or cardiac block defined by the New York Heart Association).
• Decompensated cirrhosis.
• The following conditions occur within 6 months before treatment:

Sponsors & Collaborators

• AnewPharma: lead
• Shanghai East Hospital: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Interventions

vorolanib

Study Officials

• Jin Li, M.D

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The initial dose is set at 200 mg, followed by 400 mg, 600 mg and 800 mg for dose increment.

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: January 4, 2019
• Study Start: February 26, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CN (1)