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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA196200 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research is to test the safety of the study drug (OK-1) and see what effects (good and bad) this drug has on patients with recurrent solid tumors.
OK-1 capsules will be given twice a day, every day in 21-day blocks of time. Each block of time is called a cycle. The cycle will be repeated until the patient or doctor no longer feel participation in the study is right for the patient. There will be lab tests and examinations to monitor the patients progress. We expect that taking part in this research will last up to three years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OK-1 capsule | Experimental | OK-1 (oral, BID) within a 21-days cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OK-1 | Drug | OK-1 orally in the form of 50 mg capsules. Four dose levels will be evaluated: 5.4mg/kg 7.0mg/kg 9.0mg/kg 12mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of dose-limiting toxicities of treatment with OK-1 | 21 days | |
| Dosage Recommendation for Phase 2 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of objective response | up to three years | |
| Median duration of response | up to three years | |
| Rate of disease control |
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Inclusion Criteria:
Patients must have adequate:
Exclusion Criteria:
NOTE: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging (using the identical imaging modality for each assessment, either magnetic resonance imaging [MRI] or computed tomography [CT] scan) for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability
Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
Note: If the patient underwent major surgery, she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingrid Block | Contact | 1-405-271-8777 | SCC-IIT-Office@ouhsc.edu | |
| Lead Gynecology Oncology Nurse | Contact | 1-405-271-8777 | SCC-IIT-Office@ouhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Debra Richardson, MD | Stephenson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41677630 | Derived | Mortan LF, Isingizwe ZR, Benbrook DM. Identification and Experimental Validation of Triosephosphate Isomerase 1 as a Functional Biomarker of SHetA2 Sensitivity in Ovarian Cancer. Cells. 2026 Jan 30;15(3):267. doi: 10.3390/cells15030267. |
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| up to three years |
| Median progression free survival | up to three years |
| Median overall survival | up to three years |
| Incidence of adverse events | safety and tolerability of OK-1 using Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 | up to three years |
| Tmax of PK plasma concentration | 24 hours |
| Cmax of PK plasma concentration | 24 hours |
| AUC of PK plasma concentration | 24 hours |
| t1/2 of PK plasma concentration | 24 hours |