NCT01863485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

May 22, 2013

Last Update Submit

July 2, 2019

Conditions

Advanced Cancer

Keywords

advanced cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

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

    12 months

Other Outcomes (5)

  • Preliminary biological activity

    24 months

  • Area Under Curve

    2 months

  • Half-life time

    2 months

  • +2 more other outcomes

Study Arms (1)

CM082

EXPERIMENTAL

CM082 tablet

Drug: CM082 Tablet

Interventions

CM082 TabletDRUG

CM082 tablets taken orally once a day on 28-day cycles

Also known as: X-82
CM082

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Interventions

vorolanib

Study Officials

  • Jin-Wan Wang, M.D.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

    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

May 22, 2013

First Posted

May 29, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2014

Study Completion

May 1, 2016

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

CN(3)