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This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm dose escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| belinostat | Drug | 300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU | throughout the study | |
| to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors | throughout the study |
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Inclusion Criteria:
Histologically confirmed solid tumors
Advanced colorectal cancer or other adenocarcinomas
Tumor progression after standard chemotherapy, or where none yet approved
At least one unidimensionally measurable lesion
Karnofsky performance >= 70%
Life expectancy of at least 3 months
Age >= 18 years
Signed, written Institutional Review Board (IRB)-approved informed consent
Acceptable liver function:
Acceptable renal function:
Acceptable hematologic status:
Urinalysis: No clinically significant abnormalities
Acceptable coagulation status:
For men and women of child-producing potential, use of effective contraception
Tumors accessible for needle biopsy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Topotarget A/S | Valerio Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| University of Nebraska |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D018195 | Adenosarcoma |
| D001749 | Urinary Bladder Neoplasms |
| D001943 | Breast Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018288 | Carcinoma, Small Cell |
| D002296 | Carcinosarcoma |
| D002813 | Chondrosarcoma |
| D003074 | Solitary Pulmonary Nodule |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D005153 | Facial Neoplasms |
| D005354 | Fibrosarcoma |
| D006258 | Head and Neck Neoplasms |
| D006394 | Hemangiosarcoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D014571 | Urologic Neoplasms |
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| ID | Term |
|---|---|
| C487081 | belinostat |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 5-Fluorouracil (5-FU) | Drug | 250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion. |
|
|
| Omaha |
| Nebraska |
| 68198-7680 |
| United States |
| Portsmouth Regional Hospital Hematology/Oncology Clinic | Portsmouth | New Hampshire | 03801 | United States |
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| D008175 | Lung Neoplasms |
| D008204 | Lymphangiosarcoma |
| D008654 | Mesothelioma |
| D018261 | Mesothelioma, Cystic |
| D018199 | Mixed Tumor, Mesodermal |
| D009062 | Mouth Neoplasms |
| D009217 | Myosarcoma |
| D009236 | Myxosarcoma |
| D012516 | Osteosarcoma |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010178 | Pancoast Syndrome |
| D010282 | Parathyroid Neoplasms |
| D003557 | Phyllodes Tumor |
| D047868 | Pulmonary Sclerosing Hemangioma |
| D012509 | Sarcoma |
| D013964 | Thyroid Neoplasms |
| D014134 | Tracheal Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009372 | Neoplasms, Connective Tissue |
| 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 |
| D004935 | Esophageal Diseases |
| D018218 | Neoplasms, Fibrous Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D051642 | Histiocytoma |
| D007674 | Kidney Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D018190 | Neoplasm, Lymphatic Tissue |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018213 | Neoplasms, Bone Tissue |
| D010038 | Otorhinolaryngologic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010279 | Parathyroid Diseases |
| D013959 | Thyroid Diseases |
| D014133 | Tracheal Diseases |
| D006571 |
| Heterocyclic Compounds |