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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003768-29 | EudraCT Number |
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Sponsor decision
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This is a subprotocol of Master Protocol DAY101-102 and is a Phase 1b/2, multi-center, open label subprotocol of participants ≥12 years of age, with recurrent or progressive solid tumors with alterations in the key proteins of the MAPK pathway, such as tumors that harbor RAS or RAF alterations.
*Note: Study concluded as Phase 1b only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Tovorafenib plus pimasertib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tovorafenib | Drug | Tovorafenib tablet for oral use. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who will report Treatment emergent adverse events (TEAEs) and serious TEAEs | Up to 30 days after the last dose of any study drug | |
| Number of participants who will report clinically significant changes in vital signs | Up to 30 days after the last dose of any study drug | |
| Number of participants who will report clinically significant changes in clinical chemistry parameters | Up to 30 days after the last dose of any study drug | |
| Number of participants who will report clinically significant changes in hematology parameters | Up to 30 days after the last dose of any study drug | |
| Number of participants with Dose limiting toxicities (DLTs) | Up to 30 days after the last dose of any study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with complete overall response rate (ORR) | ORR as assessed by the proportion of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate tumor response criteria as assessed by Investigator | Up to 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic | Los Angeles | California | 90025 | United States | ||
| Hoag Health |
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| Tovorafenib Drug: Pimasertib |
| Drug |
Tovorafenib tablet for oral use. Pimasertib capsule for oral use |
|
| Duration of response (DOR) |
The interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on appropriate tumor response criteria as assessed by investigator or death due to any cause, whichever occurs earlier. |
| Up to 30 months |
| Progression Free Survival (PFS) | The interval from the date of the first dose to the first occurrence of radiographic disease progression based on appropriate tumor response criteria as assessed by investigator or death due to any cause, whichever occurs earlier. | Up to 30 months |
| Overall Survival (OS) | The interval from the date of the first dose until the recorded date of death due to any cause. | Up to 30 months |
| Time to Response | Defined in participants with best overall response of CR or PR as determined by Investigator, time to response is defined as the interval from the date of the first dose to date of first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment. | Up to 30 months |
| Plasma concentration of DAY101 | Cycles 1 through Cycle 11 (each cycle is 28 days) |
| Maximum drug concentration (Cmax) of DAY101 | Cycle 1, Day 1 through Cycle 1, Day 22 |
| Area Under the Curve from Time Zero to Last Measurable Concentration (AUC 0-last) | Cycle 1, Day 1 through Cycle 1, Day 22 |
| Change in gene expression levels in pre and post treatment samples using RNA sequencing (RNA seq) analysis. | Up to 30 months |
| Change in expression levels of phosphorylated ERK (pERK) and Ki67 in pre and post treatment samples using immunohistochemistry methodology. | Up to 30 months |
| Newport Beach |
| California |
| 92663 |
| United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | United States |
| Community North Cancer Center | Indianapolis | Indiana | 46250 | United States |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | Canada |
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D001254 | Astrocytoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000626518 | tovorafenib |
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