History of Changes for Study: NCT02675946

Study of CGX1321 in Subjects With Advanced Solid Tumors

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Study Record Versions

Version	Submitted Date	Changes
1	February 3, 2016	None (earliest Version on record)
2	February 16, 2016	Recruitment Status, Study Status and Contacts/Locations
3	July 13, 2016	Contacts/Locations and Study Status
4	July 25, 2016	Contacts/Locations and Study Status
5	February 20, 2017	Contacts/Locations, Study Status, Arms and Interventions, Study Design and Study Description
6	October 23, 2017	Study Status and Contacts/Locations
7	April 5, 2018	Contacts/Locations, Arms and Interventions, Study Status, Study Description, Study Identification, Eligibility, Outcome Measures, Study Design and Conditions
8	June 4, 2018	Contacts/Locations, Study Status and Study Identification
9	June 26, 2018	Contacts/Locations and Study Status
10	July 31, 2018	Contacts/Locations and Study Status
11	May 15, 2019	Contacts/Locations, Study Status, Study Description, Eligibility and Arms and Interventions
12	September 23, 2019	Study Status and Contacts/Locations
13	September 30, 2020	Study Status, Sponsor/Collaborators and Study Identification
14	January 11, 2022	Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations, Outcome Measures, Study Design, Study Description, Study Identification and Eligibility

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CGX1321-101
Brief Title:	Study of CGX1321 in Subjects With Advanced Solid Tumors
Official Title:	A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Solid Tumors
Secondary IDs:

Study Status


Record Verification:	February 2016
Overall Status:	Not yet recruiting
Study Start:	February 2016
Primary Completion:	June 2018 [Anticipated]
Study Completion:	June 2018 [Anticipated]

First Submitted:	January 22, 2016
First Submitted that Met QC Criteria:	February 3, 2016
First Posted:	February 5, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	February 3, 2016
Last Update Posted:	February 5, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Curegenix Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description

Brief Summary:

This is a multicenter, 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.

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 solid tumors including GI tumors that have relapsed or are refractory to or not considered medically suitable to receive standard of care treatment who meet the entry criteria.

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.

Conditions


Conditions:	Solid Tumors Colorectal Adenocarcinoma Gastric Adenocarcinoma Pancreatic Adenocarcinoma Bile Duct Carcinoma Hepatocellular Carcinoma Esophageal Carcinoma
Keywords:	WNT inhibitor

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	86 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: CGX1321 Oral 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 according to the cohort they are assigned. Dose Expansion Phase: Patients will receive the recommended dose (identified in the Dose Expansion Phase) of CGX1321 once daily, orally.	Drug: CGX1321

Outcome Measures


Primary Outcome Measures:
1.	Number of participants with adverse events and/or abnormal laboratory values that are related to treatment [ Time Frame: 28 months ]
Secondary Outcome Measures:
1.	CGX1321 area under the curve [ Time Frame: 30 Days ]
2.	CGX1321 maximum or peak concentration [ Time Frame: 30 Days ]
3.	CGX1321 minimum or trough concentration [ Time Frame: 30 Days ]
4.	CGX1321 time to maximum concentration [ Time Frame: 30 Days ]
5.	CGX1321 half-life [ Time Frame: 30 Days ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: Pathologically-confirmed, locally advanced or metastatic solid tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Dose Escalation Phase) 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 (Dose Expansion Phase) Eastern Cooperative Oncology Group score of 0 - 2 Minimum life expectancy of 3 months Age 18 years or older Adequate organ function Recovery from prior treatment-related toxicities Ability to swallow tablets Willingness for patients 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 Bleeding disorder Bone abnormalities Uncontrolled central nervous system metastases or leptomeningeal metastases Requirement for immunosuppressive agents (must be off for at least 7 days) Currently receiving medications known to be inhibitors of CYP3A4/5. Subjects currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded. 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 GI impairment that may compromise absorption of study drug Pregnancy or lactation

Contacts/Locations


Central Contact Person:	Marlene Chernow Email: mchernow@us.curegenix.com
Central Contact Backup:	Lynn Nicole Email: lnicole@us.curegenix.com
Study Officials:	Kyriakos P. Papadopoulos, M.D. Principal Investigator START
Locations:	United States, Texas
	START (South Texas Accelerated Research Therapeutics, LLC) San Antonio, Texas, United States, 78229

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: