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Advanced Malignant Solid TumorsPhase 1NCT03792958

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

A Phase 1 study testing CM082 in people with Advanced Malignant Solid Tumors, run by AnewPharma at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
CM082
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
26 Feb 2019to Jun 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.
  • The results of serum pregnancy test for women of childbearing age should be negative within 7 days before treatment.
  • Men who are fertile or women who are likely to become pregnant must use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine contraceptives, sex control or barrier contraceptives combined with spermicides ) throughout the trial and continue to use contraception for 12 months after the end of treatment.
  • Patients can voluntarily sign written informed consent.

Who cannot join

  • -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.
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  • 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 have a clinically significant history of arrhythmia or current evidence of arrhythmia, but control of atrial fibrillation for more than 30 days before administration does not affect inclusion.
  • 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:
  • Deep venous thrombosis or pulmonary embolism.
  • Myocardial infarction.
  • Severe or unstable arrhythmia or angina pectoris.
  • Percutaneous Coronary Intervention, Acute Coronary Syndrome, Coronary Artery Bypass Transplantation.
  • Cerebrovascular accident, transient ischemic attack or resting limping of lower limbs.
  • Patients have not yet fully recovered from previous operations.
  • Patients who have taken strong inhibitors and inducers of CYP3A hepatic metabolic enzymes within 2 weeks before treatment.
  • Patients also take drugs that are at risk of prolonging QTc and/or Tdp.
  • Patients with a history of allergy to CM082 similar drugs (e.g., sunitinib, sorafenib, pazopanib, etc.).
  • Pregnant or lactating women.
  • Women/men with fertility who refuse to use contraception during the trial.
  • Any uncontrollable clinical problem (such as serious mental, neurological, cardiovascular, respiratory and other system diseases) or active infection that significantly affects clinical trials.
  • The patient has clinical symptoms or uncontrolled central nervous system metastasis or meningeal metastasis, which is judged by the investigator to be unsuitable for admission;
  • Patients with active upper gastrointestinal ulcer or other diseases known to affect drug absorption, distribution, metabolism or clearance.
  • Patients with obvious abnormal gastrointestinal function such as vomiting、 diarrhea, etc..
  • Positive results of HIV or Treponema pallidum antibodies (Acceptance of Treponema pallidum antibody titer test results in a Class III Grade I hospital including research centers).
  • Patients with active hepatitis B or C：
  • HBsAg or HBcAb are positive, and hepatitis B virus (HBV) DNA is detected (the results are higher than the upper limit of the normal range of the research center).
  • Hepatitis C virus (HCV) antibody test results are positive, and HCV RNA is detected (the results are higher than the upper limit of the normal range of the research center).
  • Patients who have progressed after using a receptor tyrosine kinase inhibitor that targets VEGFR.
  • Investigators consider that it is not appropriate for subjects to participate in this study from the perspective of clinical treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: Phase I Study of CM082 Tablets in the Treatment of Advanced Malignant Solid Tumors: Safety, Tolerance and Pharmacokinetics

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

Read the detailed description

This is a single-center、open-label and non-controlled Phase 1 study which will be conducted in two parts: part A is the dose-escalation phase; part B is dose-expansion phase. The dose-escalation phase is guided by pharmacokinetics (PK) and safety, according to the standard 3+3 dose-escalation schema. CM082 tablets are taken orally with a starting dose of 200 mg and a subsequent dose of 400, 600 and 800 mg. The way of administration is as follows: QD or BID. The primary objective of this study is to determine the maximum tolerable dose (MTD)、characteristics of dose-limited toxicity (DLT) and pharmacokinetics (PK). Secondary objectives include safety、tolerability and preliminary efficacy

Being tested
CM082

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM082Drug

    Also called X-82

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

Study groups in NCT03792958
Study groupRoleWhat they receive
CM082ExperimentalCM082 tablet
Receives: Drug: CM082

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerable dose (MTD) or dose to absorb saturation

    Measured: From the first dose to the 28th day of administration

  2. Dose-Limiting Toxicity

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

    Measured: From the first dose to the 28th day of administration

  3. Pharmacokinetic parameters

    Peak concentration

    Measured: From the first dose to the 28th day of administration

  4. Pharmacokinetic parameters

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

    Measured: From the first dose to the 28th day of administration

  5. Pharmacokinetic parameters

    0 to Infinite Area under Blood Drug Concentration Curve

    Measured: From the first dose to the 28th day of administration

  6. Pharmacokinetic parameters

    Peak time

    Measured: From the first dose to the 28th day of administration

  7. Pharmacokinetic parameters

    Apparent terminal elimination half-life

    Measured: From the first dose to the 28th day of administration

  8. Pharmacokinetic parameters

    Terminal elimination rate constant

    Measured: From the first dose to the 28th day of administration

Secondary outcomes (4)

  1. Objective response rate

    Measured: 12 months

  2. Disease control rate

    Measured: 12 months

  3. Progression-free survival

    Measured: 12 months

  4. Overall survival

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start26 Feb 2019
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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
Sequential
Model description
The initial dose is set at 200 mg, followed by 400 mg, 600 mg and 800 mg for dose increment.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03792958
Sponsor's protocol ID
CM082-CA-I-105
Status last verified
Nov 2022
First submitted
26 Dec 2018
Last updated
14 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CM082 in people with Advanced Malignant Solid Tumors, run by AnewPharma 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 18 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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?

Results are not available in the source record.

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?

Maximum tolerable dose (MTD) or dose to absorb saturation (time frame: From the first dose to the 28th day of administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03792958.

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 14 Nov 2022.

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