Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumors | Drug: OKI-179 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of OKI-179 as a Single Agent in Patients With Advanced Solid Tumors |
Actual Study Start Date : | May 8, 2019 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | April 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental: Phase 1 - Dose Escalation
Dose escalation trial evaluating OKI-179 given orally on a daily basis. Patients will take OKI-179 orally (PO) on Days 1 - 4, 8 - 11 and 15 - 18 in 21-day cycles (± 3 days), under fasted conditions. The design is a modified 3+3 design to determine the maximum tolerated dose. Alternatively, patients may take OKI-179 orally (PO) daily on Days 1 - 21 per 21-day cycles to determine the maximum tolerated dose for continuous daily dosing.
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Drug: OKI-179
OKI-179 single agent
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for enrollment.
Exclusion Criteria:
Patients meeting any of the following criteria are ineligible for enrollment in the study:
Note: Continuation of luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, bisphosphonates or denosumab for bone metastases.
Contact: John DeMattei, PhD | 720-310-7759 | jdemattei@onkuretherapeutics.com |
United States, Colorado | |
University of Colorado Cancer Center | Recruiting |
Aurora, Colorado, United States, 80045 | |
Principal Investigator: Jennifer Diamond, MD |
Principal Investigator: | Jennifer Diamond, MD | University of Colorado, Denver |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 17, 2019 | ||||||
First Posted Date ICMJE | April 30, 2019 | ||||||
Last Update Posted Date | October 14, 2020 | ||||||
Actual Study Start Date ICMJE | May 8, 2019 | ||||||
Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of OKI-179 in Patients With Solid Tumors | ||||||
Official Title ICMJE | A Phase 1 Study of OKI-179 as a Single Agent in Patients With Advanced Solid Tumors | ||||||
Brief Summary | This study is a Phase 1, single center, open-label study, assessing single agent dose escalation of OKI-179. | ||||||
Detailed Description | Not Provided | ||||||
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 |
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Condition ICMJE | Advanced Solid Tumors | ||||||
Intervention ICMJE | Drug: OKI-179
OKI-179 single agent
|
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Study Arms ICMJE | Experimental: Experimental: Phase 1 - Dose Escalation
Dose escalation trial evaluating OKI-179 given orally on a daily basis. Patients will take OKI-179 orally (PO) on Days 1 - 4, 8 - 11 and 15 - 18 in 21-day cycles (± 3 days), under fasted conditions. The design is a modified 3+3 design to determine the maximum tolerated dose. Alternatively, patients may take OKI-179 orally (PO) daily on Days 1 - 21 per 21-day cycles to determine the maximum tolerated dose for continuous daily dosing.
Intervention: Drug: OKI-179
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE |
21 | ||||||
Estimated Study Completion Date ICMJE | April 2021 | ||||||
Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment.
Exclusion Criteria: Patients meeting any of the following criteria are ineligible for enrollment in the study:
Note: Continuation of luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, bisphosphonates or denosumab for bone metastases.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03931681 | ||||||
Other Study ID Numbers ICMJE | OKI-179-101 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | OnKure, Inc. | ||||||
Study Sponsor ICMJE | OnKure, Inc. | ||||||
Collaborators ICMJE | University of Colorado, Denver | ||||||
Investigators ICMJE |
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PRS Account | OnKure, Inc. | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |