Status:
UNKNOWN
Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer
Lead Sponsor:
AnewPharma
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to iden...
Detailed Description
In dose escalation part, 9-18 patients with advanced gastric cancer will be enrolled. Patients meeting enrollment eligibility will receive 28-day cycles of CM082 100-200 mg qd combined with paclitaxel...
Eligibility Criteria
Inclusion
- Fully understand the study and sign the informed consent voluntarily;
- Patients with local advanced and/or metastatic gastric adenocarcinoma and/or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
- Progressed on previous first-line standard chemotherapy;
- Male or female with an age of 18-70 years(inclusive);
- Body weight ≥40 kg (inclusive);
- At least one measurable lesion (according to RECIST1.1);
- Performance status score (ECOG score) 0-1;
- Expected survival \>12 weeks;
- Adequate bonemarrow, liver, renal and cardiac function, based on blood tests, electrocardiograms, and cardiac echocardiograms.
Exclusion
- Participating in another drug clinical trial in the past 4 weeks; history of systemic anti-tumor treatment within 4 weeks prior to administration of the study drug; history of any major surgery within 4 weeks prior to enrollment to the study;
- Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE\>grade 1), or not completely recovered from previous surgery;
- Having received previous chemotherapy regimens with taxanes;
- Take medications that may extend QTc and/or Tdp;
- Active brain metastasis or meningeal metastasis;
- Uncontrolled hypertension (BP\>150/90 on medications);
- Other malignancies within the last 5 years, except for adequately treated cervix carcinoma in situ or basal or squamous-cell or basal cell carcinoma;
- QT interval \> 450 ms;
- Uncontrolled clinical active infection, e.g. acute pneumonia, active hepatitis B or hepatitis C; HIV positive; syphilitic spiral antibody positive;
- Dysphagia, intractable vomiting or known drug malabsorption;
- Drug or alcohol abuser.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03286244
Start Date
March 15 2018
End Date
August 1 2020
Last Update
February 21 2019
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China, 100021