| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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.
|
Drug: OKI-179
OKI-179 single agent
|
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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 |
|
||||||
| 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 |
||||||
| Condition ICMJE | Advanced Solid Tumors | ||||||
| Intervention ICMJE | Drug: OKI-179
OKI-179 single agent
|
||||||
| 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. |
|||||||
| 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 |
|
||||||
| 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 |
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