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This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SU011248 | Drug | Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Day 28 after last dose of study treatment |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Baseline, every 2 months until death or up to 2 years after the last dose of study treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Aurora | Colorado | 80045 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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All participants were recruited from following previous sunitinib trials: NCT00798889, NCT00092001, NCT00137449, A6181049, A6181051, NCT00113516, NCT00265317, NCT00137423, NCT00267748, NCT00243503, NCT00471276, NCT00174434, NCT00528619, NCT00372775, NCT00417885, NCT00428597, and NCT00372567.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Progression-Free Survival (PFS) | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). | Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication |
| Time to Tumor Progression (TTP) | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]). | Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication |
| Littleton |
| Colorado |
| 80120 |
| United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30322 | United States |
| Pfizer Investigational Site | Harvey | Illinois | 60426-4265 | United States |
| Pfizer Investigational Site | Harvey | Illinois | 60426 | United States |
| Pfizer Investigational Site | Maywood | Illinois | 60153 | United States |
| Pfizer Investigational Site | Tinley Park | Illinois | 60477 | United States |
| Pfizer Investigational Site | Zion | Illinois | 60099 | United States |
| Pfizer Investigational Site | Munster | Indiana | 46321 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21201 | United States |
| Pfizer Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| Pfizer Investigational Site | City of Saint Peters | Missouri | 63376 | United States |
| Pfizer Investigational Site | Creve Coeur | Missouri | 63141 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89135 | United States |
| Pfizer Investigational Site | Hackensack | New Jersey | 07601 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7600 | United States |
| Pfizer Investigational Site | Clinton | North Carolina | 28328 | United States |
| Pfizer Investigational Site | Goldsboro | North Carolina | 27534 | United States |
| Pfizer Investigational Site | Hickory | North Carolina | 28602 | United States |
| Pfizer Investigational Site | Wilson | North Carolina | 27893 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74133 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Pfizer Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Pfizer Investigational Site | Greenville | South Carolina | 29615 | United States |
| Pfizer Investigational Site | Greer | South Carolina | 29650 | United States |
| Pfizer Investigational Site | Spartanburg | South Carolina | 29307 | United States |
| Pfizer Investigational Site | Bedford | Texas | 76022 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76177 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78207 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78217 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78258 | United States |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Pfizer Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 4M1 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3G 1A4 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3G 1L5 | Canada |
| Pfizer Investigational Site | Lyon | 69373 | France |
| Pfizer Investigational Site | Marseille | 13915 | France |
| Pfizer Investigational Site | Villejuif | 94805 | France |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Großhansdorf | 22927 | Germany |
| Pfizer Investigational Site | Hamburg | 20246 | Germany |
| Pfizer Investigational Site | Wiesbaden | 65199 | Germany |
| Pfizer Investigational Site | Bologna | 40138 | Italy |
| Pfizer Investigational Site | Cremona | 26100 | Italy |
| Pfizer Investigational Site | Genova | 16132 | Italy |
| Pfizer Investigational Site | Milan | 20133 | Italy |
| Pfizer Investigational Site | Orbassano (TO) | 10043 | Italy |
| Pfizer Investigational Site | Rozzano (MI) | 20089 | Italy |
| Pfizer Investigational Site | Elche | Alicante | 03203 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08003 | Spain |
| Pfizer Investigational Site | Córdoba | Cordoba | 14004 | Spain |
| Pfizer Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| Pfizer Investigational Site | London | SW3 6JJ | United Kingdom |
| Pfizer Investigational Site | Manchester | M20 4BX | United Kingdom |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Intent to treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | participants | Baseline up to Day 28 after last dose of study treatment |
|
|
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Overall Survival (OS) | Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies. | Posted | Baseline, every 2 months until death or up to 2 years after the last dose of study treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Progression-Free Survival (PFS) | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). | Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies. | Posted | Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Tumor Progression (TTP) | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]). | Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies. | Posted | Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib | Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing). | 35 | 122 | 115 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
The reason for not completed 'Study Terminated by Sponsor' in participant flow table indicates the termination of study at few sites as captured in case report forms at those sites and does not reflect overall status of study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided