S1609 FAQ

UPCOMING DART COHORT CLOSURES AS OF 19-APR-2024 6:10 AM

ENTIRE S1609 STUDY IS CLOSED TO ACCRUAL AS OF 03/15/23

# COHORT Name Up-coming
Closure Date		 Closure Type
  No up-coming closures to report    

CLOSED DART COHORTS AS OF 19-APR-2024 6:10 AM

Closure Type # COHORT NAME TOTAL
REGS.		 REGS.
LAST
12
Month		 REGS.
LAST
6
Month		 REGS.
LAST
3
Month		 REGS.
LAST
30
DAYS		 REGS.
LAST
7
DAYS		 # of
ACT.
INSTs		 # of
CURR
IRBs
Permanent Close 1 Epithelial tumors of nasal cavity, sinuses, nasopharynx 7 0 0 0 0 0 17 5
Permanent Close 2 Epithelial tumors of major salivary glands 30 0 0 0 0 0    
Permanent Close 3 Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location 6 0 0 0 0 0    
Permanent Close 4 Undifferentiated carcinoma of gastrointestinal (GI) tract 6 0 0 0 0 0    
Permanent Close 5 Adenocarcinoma with variants of small intestine 26 0 0 0 0 0    
Permanent Close 6 Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) 6 0 0 0 0 0    
Permanent Close 7 Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary 10 0 0 0 0 0    
Permanent Close 8 Rare Pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma 11 0 0 0 0 0    
Permanent Close 9 Intrahepatic cholangiocarcinoma 9 0 0 0 0 0    
Permanent Close 10 Extrahepatic cholangiocarcinoma and bile duct tumors 10 0 0 0 0 0    
Permanent Close 13 Non-epithelial tumors of the ovary 17 0 0 0 0 0    
Permanent Close 14 Trophoblastic tumor 3 0 0 0 0 0    
Permanent Close 15 Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder 1 0 0 0 0 0    
Permanent Close 16 Cell tumor of the testes and extragonadal germ tumors 17 0 0 0 0 0    
Permanent Close 17 Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 23 0 0 0 0 0    
Permanent Close 18 Squamous cell carcinoma variants of the genitourinary (GU) system 7 0 0 0 0 0    
Permanent Close 20 Adenocarcinoma with variants of GU system (excluding prostate cancer) 9 0 0 0 0 0    
Permanent Close 21 Odontogenic malignant tumors 4 0 0 0 0 0    
Permanent Close 22 Pancreatic neuroendocrine tumor (PNET) 22 0 0 0 0 0    
Permanent Close 23 Neuroendocrine carcinoma including carcinoid of the lung 35 0 0 0 0 0    
Permanent Close 24 Pheochromocytoma, malignant 7 0 0 0 0 0    
Permanent Close 25 Paraganglioma 6 0 0 0 0 0    
Permanent Close 26 Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 21 0 0 0 0 0    
Permanent Close 27 Desmoid tumors 17 0 0 0 0 0    
Permanent Close 28 Peripheral nerve sheath tumors and NF1-related tumors 9 0 0 0 0 0    
Permanent Close 29 Malignant giant cell tumors 6 0 0 0 0 0    
Permanent Close 30 Chordoma 11 0 0 0 0 0    
Permanent Close 31 Adrenal cortical tumors 23 0 0 0 0 0    
Permanent Close 32 Tumor of unknown primary (Cancer of Unknown Primary; CuP) 26 0 0 0 0 0    
Permanent Close 33 Not Otherwise Categorized (NOC) Rare Tumors, after discussion with Study Chairs 65 0 0 0 0 0    
Permanent Close 34 Adenoid cystic carcinoma 29 0 0 0 0 0    
Permanent Close 35 Vulvar cancer 17 0 0 0 0 0    
Permanent Close 36 MetaPLASTIC carcinoma (of the breast) 19 0 0 0 0 0    
Permanent Close 37 Gastrointestinal stromal tumor (GIST) 12 0 0 0 0 0    
Permanent Close 38 Perivascular epithelioid cell tumor (PEComa) 17 0 0 0 0 0    
Permanent Close 39 Apocrine tumors/Extramammary Paget’s Disease 9 0 0 0 0 0    
Temporary Close 40 Peritoneal mesothelioma 18 0 0 0 0 0    
Permanent Close 41 Basal cell carcinoma 18 0 0 0 0 0    
Permanent Close 42 Clear cell cervical cancer 5 0 0 0 0 0    
Permanent Close 43 Esthenioneuroblastoma 7 0 0 0 0 0    
Permanent Close 44 Endometrial carcinosarcoma (malignant mixed Mullerian tumors) 25 0 0 0 0 0    
Permanent Close 45 Clear cell endometrial cancer 9 0 0 0 0 0    
Temporary Close 46 Clear cell ovarian cancer 25 0 0 0 0 0    
Permanent Close 48 Gallbladder cancer 22 0 0 0 0 0    
Permanent Close 51 Angiosarcoma 18 0 0 0 0 0    
Permanent Close 52 High-grade neuroendocrine carcinoma 21 0 0 0 0 0    
Permanent Close 53 Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) 19 0 0 0 0 0    

DART ACCRUAL REPORT

ENTIRE S1609 STUDY IS CLOSED TO ACCRUAL AS OF 03/15/23

Status # COHORT NAME TOTAL
REGS.		 REGS.
LAST
12
Month		 REGS.
LAST
6
Month		 REGS.
LAST
3
Month		 REGS.
LAST
30
DAYS		 REGS.
LAST
7
DAYS		 # of
ACT.
INSTs		 # of
CURR
IRBs
Permanent Close 1 Epithelial tumors of nasal cavity, sinuses, nasopharynx 7 0 0 0 0 0 17 5
Permanent Close 2 Epithelial tumors of major salivary glands 30 0 0 0 0 0    
Permanent Close 3 Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location 6 0 0 0 0 0    
Permanent Close 4 Undifferentiated carcinoma of gastrointestinal (GI) tract 6 0 0 0 0 0    
Permanent Close 5 Adenocarcinoma with variants of small intestine 26 0 0 0 0 0    
Permanent Close 6 Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) 6 0 0 0 0 0    
Permanent Close 7 Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary 10 0 0 0 0 0    
Permanent Close 8 Rare Pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma 11 0 0 0 0 0    
Permanent Close 9 Intrahepatic cholangiocarcinoma 9 0 0 0 0 0    
Permanent Close 10 Extrahepatic cholangiocarcinoma and bile duct tumors 10 0 0 0 0 0    
Open 11 Sarcomatoid carcinoma of lung 16 0 0 0 0 0    
Open 12 Bronchoalveolar carcinoma lung (a.k.a. adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma) 8 0 0 0 0 0    
Permanent Close 13 Non-epithelial tumors of the ovary 17 0 0 0 0 0    
Permanent Close 14 Trophoblastic tumor 3 0 0 0 0 0    
Permanent Close 15 Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder 1 0 0 0 0 0    
Permanent Close 16 Cell tumor of the testes and extragonadal germ tumors 17 0 0 0 0 0    
Permanent Close 17 Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 23 0 0 0 0 0    
Permanent Close 18 Squamous cell carcinoma variants of the genitourinary (GU) system 7 0 0 0 0 0    
Open 19 Spindle cell carcinoma of kidney, pelvis, ureter 10 0 0 0 0 0    
Permanent Close 20 Adenocarcinoma with variants of GU system (excluding prostate cancer) 9 0 0 0 0 0    
Permanent Close 21 Odontogenic malignant tumors 4 0 0 0 0 0    
Permanent Close 22 Pancreatic neuroendocrine tumor (PNET) 22 0 0 0 0 0    
Permanent Close 23 Neuroendocrine carcinoma including carcinoid of the lung 35 0 0 0 0 0    
Permanent Close 24 Pheochromocytoma, malignant 7 0 0 0 0 0    
Permanent Close 25 Paraganglioma 6 0 0 0 0 0    
Permanent Close 26 Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 21 0 0 0 0 0    
Permanent Close 27 Desmoid tumors 17 0 0 0 0 0    
Permanent Close 28 Peripheral nerve sheath tumors and NF1-related tumors 9 0 0 0 0 0    
Permanent Close 29 Malignant giant cell tumors 6 0 0 0 0 0    
Permanent Close 30 Chordoma 11 0 0 0 0 0    
Permanent Close 31 Adrenal cortical tumors 23 0 0 0 0 0    
Permanent Close 32 Tumor of unknown primary (Cancer of Unknown Primary; CuP) 26 0 0 0 0 0    
Permanent Close 33 Not Otherwise Categorized (NOC) Rare Tumors, after discussion with Study Chairs 65 0 0 0 0 0    
Permanent Close 34 Adenoid cystic carcinoma 29 0 0 0 0 0    
Permanent Close 35 Vulvar cancer 17 0 0 0 0 0    
Permanent Close 36 MetaPLASTIC carcinoma (of the breast) 19 0 0 0 0 0    
Permanent Close 37 Gastrointestinal stromal tumor (GIST) 12 0 0 0 0 0    
Permanent Close 38 Perivascular epithelioid cell tumor (PEComa) 17 0 0 0 0 0    
Permanent Close 39 Apocrine tumors/Extramammary Paget’s Disease 9 0 0 0 0 0    
Temporary Close 40 Peritoneal mesothelioma 18 0 0 0 0 0    
Permanent Close 41 Basal cell carcinoma 18 0 0 0 0 0    
Permanent Close 42 Clear cell cervical cancer 5 0 0 0 0 0    
Permanent Close 43 Esthenioneuroblastoma 7 0 0 0 0 0    
Permanent Close 44 Endometrial carcinosarcoma (malignant mixed Mullerian tumors) 25 0 0 0 0 0    
Permanent Close 45 Clear cell endometrial cancer 9 0 0 0 0 0    
Temporary Close 46 Clear cell ovarian cancer 25 0 0 0 0 0    
Open 47 Gestational trophoblastic disease (GTD) 4 0 0 0 0 0    
Permanent Close 48 Gallbladder cancer 22 0 0 0 0 0    
Open 49 Small cell carcinoma of the ovary, hypercalcemic type 7 0 0 0 0 0    
Open 50 PD-L1 amplified tumors (single-agent Nivolumab therapy) 13 0 0 0 0 0    
Permanent Close 51 Angiosarcoma 18 0 0 0 0 0    
Permanent Close 52 High-grade neuroendocrine carcinoma 21 0 0 0 0 0    
Permanent Close 53 Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) 19 0 0 0 0 0    
    TOTAL 798 0 0 0 0 0