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Study was terminated due to sponsor decision. This decision was not related to safety concerns.
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This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXIN1 Cohort | Experimental | Participants will receive REC-4881 12mg PO dosed QD |
|
| APC Cohort | Experimental | Participants will receive REC-4881 12mg PO dosed QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REC-4881 | Drug | REC-4881 4mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities | Up to 24 months | |
| Objective Response Rate | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) of REC-4881 | pre-dose and up to 24 months | |
| Disease Control Rate | Up to 24 months | |
| Duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States | ||
| Sansum Clinic |
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Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.
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| Up to 24 months |
| Duration of Stable Disease | Up to 24 months |
| Time to Response | Up to 24 months |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| Eastern Connecticut Hematology & Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Medical Oncology Hematology Consultants | Newark | Delaware | 19713 | United States |
| Cancer Specialists of North Florida | Fleming Island | Florida | 32003 | United States |
| Mission Cancer And Blood | Des Moines | Iowa | 50314 | United States |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Hunterdon Hematology Oncology | Hillsborough | New Jersey | 08844 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Mary Crowley Cancer Research Centers | Dallas | Texas | 75231 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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