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| Name | Class |
|---|---|
| BTG International Inc. | OTHER |
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The purpose of this study is to evaluate the safety and impact on survival with treatment with 90-Y glass microspheres in conjunction with leucovorin, 5-fluorouracil (5-FU) and oxaliplatin (FOLFOX) as second-line treatment with in patients gemcitabine-refractory metastatic pancreatic cancer with predominantly liver metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2nd Line Chemotherapy With Radiotherapy | Experimental | Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy is given every two weeks for 6-10 cycles. The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) | Drug | The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) | OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate. | Up to 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Progression Free Survival (PFS) | PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate. |
Not provided
Inclusion Criteria:
Patients must have metastatic pancreatic cancer with predominantly liver metastatic disease (> 50%), as determined by the principal investigator (PI0 and referring medical oncologist that have progressed on gemcitabine-based chemotherapy.
Patients can have solitary, multifocal unilobar, or bilobar disease.
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
No prior radiation or embolization of the liver
Childs-Pugh score ≤ 7
Lung shunting that predicts lung dose to be ≤ 30 Gy in a single treatment
The effects of TheraSpheres on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radioactive spheres are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document
Adequate baseline hematopoietic function:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Hoffe, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
Not provided
Participants were enrolled at Moffitt Cancer Center June 2012 through March 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 2nd Line Chemotherapy With Radiotherapy | Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy is given every two weeks for 6-10 cycles. The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment. TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants. Outcome Measures may reference participants evaluable at time of analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2nd Line Chemotherapy With Radiotherapy | Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Overall Survival (OS) | OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate. | All participants evaluable at time of analysis | Posted | Median | 95% Confidence Interval | months | Up to 29 months |
|
30 months
All Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported regardless of causality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2nd Line Chemotherapy With Radiotherapy | Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy was to be given every two weeks for 6-10 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Hoffe | H. Lee Moffitt Cancer Center and Research Institute | 813-745-4380 | sarah.hoffe@moffitt.org |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| C410216 | Folfox protocol |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| TheraSpheres | Device | TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver. TheraSpheres have restricted approval from the United States Food and Drug Administration (FDA) for the treatment of hepatocellular liver cancer; but has not yet been approved for the treatment of pancreatic cancer that has spread to the liver. |
|
|
| Up to 29 months |
| Overall Response Rate (ORR) | The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups. | Up to 29 months |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Rate of Progression Free Survival (PFS) | PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate. | All participants evaluable at time of analysis | Posted | Count of Participants | Participants | Up to 29 months |
|
|
|
| Secondary | Overall Response Rate (ORR) | The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups. | All participants evaluable at time of analysis | Posted | Count of Participants | Participants | Up to 29 months |
|
|
|
| 5 |
| 9 |
| 8 |
| 9 |
| Atrial fibrillation | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify - melena | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Death NOS | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Malaise | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Biliary tract infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Watering eyes | Eye disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify - stool color changes | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Malaise | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| General disorders and administration site conditions - Other, thrush | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hepatobiliary disorders - Other, jaundice | Hepatobiliary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Biliary tract infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| INR increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Weight gain | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Investigations - Other, Prothrombin time increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorders - Other, muscle cramps | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, discoloration | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D008107 |
| Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |