- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507998
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced GI tumors that have relapsed or are refractory to or not considered medically suitable to receive standard of care treatment.
Once the dose is identified in the Dose Escalation Phase, the Dose Expansion Phase will start. The purpose of the Dose Expansion Phase is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 when administered to subjects with advanced GI tumors who meet the entry criteria.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Peter Ding
- Phone Number: (86)020-32299929
- Email: pding@curegenix.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Jifang Gong
- Phone Number: 86 13683208528
- Email: goodjf@163.com
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Beijing, China
- Recruiting
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Aiping Zhou, MD
-
Contact:
- Wen Zhang, MD
- Phone Number: 86 18611643302
- Email: wenwen0605@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically-diagnosed advanced Gl tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment
- Eastern Cooperative Oncology Group (ECOG) score of 0 - 1
- Minimum estimated life expectancy of 3 months
- Adequate organ function
- Recovery from prior treatment-related toxicities
- Ability to swallow capsules
- Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment
Exclusion Criteria:
- Prior exposure to a WNT inhibitor
- Received previous therapy for malignancy within 21 days
- Major surgery within 4 weeks of first dose of study drug
- Radiotherapy within 2 weeks of first dose of study drug
- Significant GI or variceal bleeding or subdural hematoma within 3 months of treatment start
- Uncontrolled central nervous system metastases or leptomeningeal metastases
- Requirement for immunosuppressive agents (must be off for at least 7 days)
- Currently receiving medications that are known CYP3A4/5 inhibitors. Patients currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded.
- Bone abnormalities
- Hypercalcemia
- Cardiac abnormalities
- Known human immunodeficiency virus positive, or active hepatitis A, B or C
- History of additional prior malignancy with the exception of surgically cured carcinomas such as skin, prostate, bladder, thyroid, cervix or other carcinomas in situ
- Active systemic infection requiring intravenous antibiotics within 2 weeks of treatment start
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CGX1321 Dosing
Dose Escalation Phase: Ascending doses of CGX1321 will be administered by cohort to determine the maximum tolerated dose. Patients will receive CGX1321, once daily, orally, for 3 weeks (21 days) followed by a one week (7 day) washout period in each 28 day cycle, according to the cohort they are assigned. Dose Expansion Phase: Patients will receive the recommended dose (identified in the Dose Expansion Phase) of CGX1321 |
CGX1321 capsules for oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment
Time Frame: 21 months
|
21 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CGX1321 maximum or peak concentration
Time Frame: 30 days
|
30 days
|
CGX1321 minimum or trough concentration
Time Frame: 30 days
|
30 days
|
CGX1321 time to maximum concentration
Time Frame: 30 days
|
30 days
|
CGX1321 half life
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma
- Adenocarcinoma
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Esophageal Neoplasms
- Carcinoma, Ductal
Other Study ID Numbers
- CGX1321-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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