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Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

Sponsor
AnewPharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01863485
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
44
Enrollment
3
Locations
1
Arm
36
Duration (Months)
14.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.

Condition or Disease Intervention/Treatment Phase
  • Drug: CM082 Tablet
 Phase 1

Detailed Description

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of ~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: CM082

CM082 tablet

Drug: CM082 Tablet
CM082 tablets taken orally once a day on 28-day cycles
Other Names:
  • X-82

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose [12 months]

      To determine the Maximum Tolerated Dose in Chinese patients with advanced solid tumors.

    Other Outcome Measures

    1. Preliminary biological activity [24 months]

      clinical tumor response by computed tomography (CT) after treatment with CM082 tablets given as a single agent.

    2. Area Under Curve [2 months]

    3. Half-life time [2 months]

    4. Cmax [2 months]

      Peak concentration

    5. Tmax [2 months]

      Time to Cmax

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.

    • Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.

    • Life expectancy of at least 12 weeks.

    • No immuno deficiency.

    • Adequate organ system function, defined as follows:

    • Absolute neutrophil count (ANC) ≥1.5 x 10**9/L

    • Platelets ≥100 x 10**9/L

    • Hemoglobin ≥10 g/dL

    • Total bilirubin ≤1.5 times the upper limit of normal (ULN)

    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤2.5x the upper limit of normal with liver involvement.

    • Creatinine ≤ 1.5 x ULN.

    • At least 4 weeks or 5 half-life after receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization.

    • Willingness and ability to comply with trial and follow-up procedures.

    • Ability to understand the nature of this trial and give written informed consent.

    Exclusion Criteria:

    • Not recovered from prior anti-cancer therapy or surgery.

    • Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.

    • Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.

    • Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).

    • Females who are pregnant or breastfeeding.

    • Those in reproductive ages who refuse to use contraception.

    • Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol.

    • Patients with known central nervous system (CNS) metastases.

    • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 (X-82).

    • Patients with known GI disorders such as vomiting, diarrhea.

    • Patients who are hepatitis B virus positive.

    • Drug abuser.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing University First Hospital Beijing Beijing China 100034
    2 Tianjin Cancer Hospital Tianjin Tianjin China 300060
    3 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing China 100021

    Sponsors and Collaborators

    • AnewPharma
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Investigators

    • Principal Investigator: Jin-Wan Wang, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AnewPharma
    ClinicalTrials.gov Identifier:
    NCT01863485
    Other Study ID Numbers:
    • CM082-CA-I-001
    • 2013L00579、2013L00581
    First Posted:
    May 29, 2013
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by AnewPharma
    advanced cancer
    Additional relevant MeSH terms:
    Neoplasms
    Vorolanib

    Study Results

    No Results Posted as of Jul 5, 2019