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Trial terminated due to a business decision, not based on any safety concerns.
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This is a multicenter clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCC-3084 Module A Escalation Phase (ModA Part 1) | Experimental | Participants will receive DCC-3084 in ModA Part 1, Escalation Phase. |
|
| DCC-3084 Module A Expansion Phase (ModA Part 2) | Experimental | Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCC-3084 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1) | DLTs reported during ModA Part 1. | Cycle 1 (28 days) |
| Objective Response Rate (ORR) (ModA Part 2) | ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol. | Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (ModA Part 1) | ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol. | Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months) |
| Progression-Free Survival (PFS) (ModA Part 1 and 2) |
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Inclusion Criteria:
General Inclusion Criteria ModA Part 1 and 2:
Inclusion Criteria ModA Part 1 Cohort Specific:
Inclusion Criteria ModA Part 2 Cohort Specific:
Exclusion Criteria:
General Exclusion Criteria ModA Part 1 and 2:
Exclusion Criteria: Module A Part 2 Cohort Specific:
• Has known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, Phosphoinositide-3-kinase, catalytic, alpha polypeptide (PI3KCA), or Phosphatase and TENsin homolog deleted on chromosome 10 (PTEN)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California - Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
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PFS is the time from start of therapy to PD or death due to any cause. |
| Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months) |
| Overall Survival (OS) (ModA Part 1 and 2) | OS is the time from start of therapy to death from any cause. | Start of Therapy to Death Due to Any Cause (Estimated up to 36 months) |
| Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2) | Cmax (ModA Part 1 and 2) | Predose up to 12 hours postdose |
| University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center |
| San Francisco |
| California |
| 94158 |
| United States |
| SCRI HealthONE | Denver | Colorado | 80218 | United States |
| SCRI Florida Cancer Specialists | Orlando | Florida | 32827 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| NEXT Oncology Virginia | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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