AOH1996 for the Treatment of Refractory Solid Tumors
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05227326 |
Recruitment Status :
Active, not recruiting
First Posted : February 7, 2022
Last Update Posted : April 10, 2024
|
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | January 11, 2022 | ||||||
First Posted Date ICMJE | February 7, 2022 | ||||||
Last Update Posted Date | April 10, 2024 | ||||||
Actual Study Start Date ICMJE | August 12, 2022 | ||||||
Estimated Primary Completion Date | September 28, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
Levels of plasma gammaH2AX [ Time Frame: Up to 2 years ] Will use descriptive statistics and graphical displays to summarize levels of plasma gammaH2AX, evaluate changes between pre- and post-treatment measurements. A paired t-test will be used to determine if there is a statistically significant change.
|
||||||
Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | AOH1996 for the Treatment of Refractory Solid Tumors | ||||||
Official Title ICMJE | First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors | ||||||
Brief Summary | This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. | ||||||
Detailed Description | PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PCNA inhibitor AOH1996 (AOH1996). II. To establish the recommended phase 2 dose (RP2D) of AOH1996. SECONDARY OBJECTIVES: I. To determine the pharmacokinetics of AOH1996. II. To evaluate for preliminary efficacy of AOH1996. III. To evaluate response rate and disease control rate in solid tumors. EXPLORATORY OBJECTIVE: I. To determine pharmacodynamics parameters (alteration of gammaH2AX, downregulation of Myc) of AOH1996. OUTLINE: This is a dose-escalation study. Patients receive AOH1996 orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. |
||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE | Refractory Malignant Solid Neoplasm | ||||||
Intervention ICMJE | Drug: PCNA Inhibitor AOH1996
Given PO
Other Names:
|
||||||
Study Arms ICMJE | Experimental: Treatment (PCNA inhibitor AOH1996)
Patients receive PCNA inhibitor AOH1996 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: PCNA Inhibitor AOH1996
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
6 | ||||||
Original Estimated Enrollment ICMJE |
27 | ||||||
Estimated Study Completion Date ICMJE | September 28, 2024 | ||||||
Estimated Primary Completion Date | September 28, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05227326 | ||||||
Other Study ID Numbers ICMJE | 21310 NCI-2021-14102 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 21310 ( Other Identifier: City of Hope Medical Center ) P30CA033572 ( U.S. NIH Grant/Contract ) |
||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | City of Hope Medical Center | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | City of Hope Medical Center | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||
Investigators ICMJE |
|
||||||
PRS Account | City of Hope Medical Center | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |