[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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Study’s contact

Call center

010-56532595

Email address

yangjing@biotellconsulting.com

Condition

Bile Duct Carcinoma,Colorectal Adenocarcinoma,Esophageal Carcinoma,Gastric Adenocarcinoma,Gastrointestinal Cancer,Hepatocellular Carcinoma,Pancreatic Adenocarcinoma

Treatment type

Interventional

Investigational product

CGX1321

Phase

Phase 1

Sponsor

Curegenix Inc.

ClinicalTrials.gov identifier

NCT03507998

Study number

CGX1321-102

Understanding clinical trials

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About the study

This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. 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
  2. Eastern Cooperative Oncology Group (ECOG) score of 0
  3. 1
  4. Minimum estimated life expectancy of 3 months
  5. Adequate organ function
  6. Recovery from prior treatment-related toxicities
  7. Ability to swallow capsules
  8. Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment
Exclusion criteria
  1. Prior exposure to a WNT inhibitor
  2. Received previous therapy for malignancy within 21 days
  3. Major surgery within 4 weeks of first dose of study drug
  4. Radiotherapy within 2 weeks of first dose of study drug
  5. Significant GI or variceal bleeding or subdural hematoma within 3 months of treatment start
  6. Uncontrolled central nervous system metastases or leptomeningeal metastases
  7. Requirement for immunosuppressive agents (must be off for at least 7 days)
  8. 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.
  9. Bone abnormalities
  10. Hypercalcemia
  11. Cardiac abnormalities
  12. Known human immunodeficiency virus positive, or active hepatitis A, B or C
  13. History of additional prior malignancy with the exception of surgically cured carcinomas such as skin, prostate, bladder, thyroid, cervix or other carcinomas in situ
  14. Active systemic infection requiring intravenous antibiotics within 2 weeks of treatment start
  15. Pregnancy or lactation

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site