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The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | CP-383, single daily oral capsule, 0.8 mg |
|
| Dose Level 2 | Experimental | CP-383, single daily oral capsule, 1.6 mg |
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| Dose Level 3 | Experimental | CP-383, single daily oral capsule, 3.0 mg |
|
| Dose Level 4 | Experimental | CP-383, single daily oral capsule, 5.0 mg |
|
| Dose Level 5 | Experimental | CP-383, single daily oral capsule, 8.0 mg |
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| Dose Level 6 | Experimental | CP-383, single daily oral capsule, 12 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-383 | Drug | Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Determine the maximum tolerated dose (MTD) | Determine the MTD of CP-383 in subjects with advanced solid tumors | 21 days |
| Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types | Objective response rate assessed by the investigator according to RECIST | From enrollment through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Determine the pharmacokinetics parameters of CP-383 | Assess standard PK parameters including Cmax | From enrollment through study completion, an average of 1 year |
| Part 1: Determine the pharmacokinetics parameters of CP-383 |
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Inclusion Criteria:
Measurable or non measurable cancer that the research can assess for changes
Not eligible or able to take existing standard therapies for cancer
Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor
Diagnosed with locally advanced, recurrent or metastatic incurable disease
Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment
Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer
Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer
_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
Adequate blood and urine lab tests
Women and men of childbearing potential with adequate contraception
Provides written informed consent
Willing to comply with the requirements of the protocol
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tasca Therapeutics | Contact | 617-430-7109 | trials@tascatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Recruiting | Denver | Colorado | 80218 | United States |
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| Expansion Arm 1 |
| Experimental |
Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
|
| Expansion Arm 2 | Experimental | Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
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| Expansion Arm 3 | Experimental | Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
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| Expansion Arm 4 | Experimental | Expansion in selected tumor type at recommended Phase 2 Dose of CP-383 |
|
Assess standard PK parameters including tmax
| From enrollment through study completion, an average of 1 year |
| Part 1: Determine the pharmacokinetics parameters of CP-383 | Assess standard PK parameters including AUC | From enrollment through study completion, an average of 1 year |
| Part 1: Assess safety and tolerability of CP-383 in participants with advanced solid tumors | Incidence and severity of Adverse events and changes in test results | From enrollment through study completion, an average of 1 year |
| Part 2: Evaluate safety and tolerability of CP-383 at the recommended Phase 2 dose in selected tumor types | Incidence of AEs and changes in test results | From enrollment through study completion, an average of 1 year |
| Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types | Evaluate duration of response | From enrollment through study completion, an average of 1 year |
| Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types | Evaluate disease control as determined by Objective response of CR, PR or SD for at least 6 months | From enrollment through study completion, an average of 1 year |
| Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types | Evaluate progression free survival | From enrollment through study completion, an average of 1 year |
| Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types | Evaluate overall survival | From enrollment through study completion, an average of 1 year |
| Florida Cancer Specialists-Lake Nona | Recruiting | Orlando | Florida | 32827 | United States |
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| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
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| Carolina BioOncology Institute | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Taylor Cancer Research Center | Recruiting | Maumee | Ohio | 43537 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| NEXT Oncology - Dallas | Recruiting | Dallas | Texas | 75039 | United States |
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| START San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
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| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001749 | Urinary Bladder Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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