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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01416 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB#13-028/ERP-GYN-064 | Other Identifier | Fox Chase Cancer Center | |
| P30CA006927 | U.S. NIH Grant/Contract | View source |
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Study drug is no longer supplied by grantor.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I/II trial studies the side effects and best dose of ganetespib when given together with paclitaxel and to see how well they work in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and ganetespib may be an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer.
PRIMARY OBJECTIVES:
I. Determine the recommended Phase II dose of ganetespib with weekly paclitaxel. (Phase I) II. Probability of surviving progression-free for at least 6 months after initiating therapy. (Phase II) III. Clinical response rate (partial and complete responses as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). (Phase II)
SECONDARY OBJECTIVES:
I. Determine the nature and degree of toxicity of ganetespib and weekly paclitaxel in this cohort of patients as measured by the frequency and severity of adverse reactions. (Phase I) II. Determine the nature and degree of toxicity of ganetespib and weekly paclitaxel in this cohort of patients as measured by the frequency and severity of adverse reactions encountered. (Phase II) III. Duration of progression-free survival. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of ganetespib followed by a phase II study.
Patients receive paclitaxel intravenously (IV) over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: 100 mg/m2 ganetespib, 80 mg/m2 paclitaxel | Experimental | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
|
| Phase I: 125 mg/m2 ganetespib, 80 mg/m2 paclitaxel | Experimental | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
|
| Phase I: 150 mg/m2 ganetespib, 80 mg/m2 paclitaxel | Experimental | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
|
| Phase II: MTD/MED of ganetespib, 80 mg/m2 paclitaxel | Experimental | Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase II Dose of Ganetespib With Weekly Paclitaxel, Based on the Incidence of Dose-limiting Toxicity (DLT) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 (Phase I) | Up to 28 days | |
| Progression-free Survival at 6 Months (Phase II) | From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months | |
| Response Rate Defined as the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR) Per RECIST v. 1.1 (Phase II) | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-free Survival (Phase II) | From start of treatment to time of progression or death, whichever occurs first, assessed up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have had surgery, chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have toxicity that has not recovered to =< grade 1 from adverse events due to agents administered more than 4 weeks earlier (with the exception of alopecia); patients may not be receiving any other investigational agents
Histologic diagnosis of a benign or borderline tumor ('tumor of low malignant potential') or of a malignant tumor of non-epithelial origin (such as a germ cell tumor, sex-cord stromal tumor) of the ovary, fallopian tube or peritoneum
Patients with known brain metastases
History of allergic reactions to Cremophor EL, paclitaxel or its components
Prior history of >= grade 2 neurotoxicity or any other toxicity requiring discontinuation of taxane therapy that has not resolved to =< grade 1, with the exception of alopecia
Diagnosis of another malignancy within two years before the first dose, or previously treated for another malignancy with evidence of residual disease, with the exception of a synchronous endometrial cancer; carcinoma in situ will not be considered as malignancy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, known serious cardiac illness or psychiatric illness/social situations that would limit compliance with study requirements; known serious cardiac illness or medical conditions include, but are not limited to:
History of documented congestive heart failure (CHF), New York Heart Association (NYHA) class II/III/IV, with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, beta blockers, or diuretics
Screening QTc (QT interval corrected for heart rate) > 470 msec or history of QT (cardiac interval from start of Q wave to end of T wave) prolongation while taking other medications
High-risk uncontrolled arrhythmias (ventricular arrhythmias, high-grade atrioventricular [AV]-block, supra-ventricular arrhythmias that are not adequately rate-controlled)
Arrhythmias that require current treatment with the following anti-arrhythmic drugs: flecainide, moricizine, or propafenone
Current coronary artery disease with a history of myocardial infarction, angioplasty, or coronary bypass surgery within the preceding 6 months, or angina pectoris that has been symptomatic within the preceding 6 months
Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Pregnant or breast feeding
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| Name | Affiliation | Role |
|---|---|---|
| Gina Martina-Smaldone, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2018 |
Not provided
Phase I Treatment: Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at a starting dose of 100 mg/m2 on days 1, 8 and 15 of a 28-day cycle. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. Phase II Treatment: Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
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|
|
| ganetespib | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Fox Chase Cancer Center |
| Philadelphia |
| Pennsylvania |
| 19111-2497 |
| United States |
| FG001 |
| Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel |
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
| FG002 | Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
| FG003 | Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel | Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
| BG001 | Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
| BG002 | Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. |
| BG003 | Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel | Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle. |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Recommended Phase II Dose of Ganetespib With Weekly Paclitaxel, Based on the Incidence of Dose-limiting Toxicity (DLT) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 (Phase I) | Posted | Number | mg/m2 ganetespib | Up to 28 days |
|
|
| ||||||||||||||||||||||||||||
| Primary | Progression-free Survival at 6 Months (Phase II) | The study was suspended prematurely due to halt in drug production and data were not analyzed | Posted | From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months |
|
| ||||||||||||||||||||||||||||||
| Primary | Response Rate Defined as the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR) Per RECIST v. 1.1 (Phase II) | The study was suspended prematurely due to halt in drug production and data were not analyzed | Posted | Up to 4 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Progression-free Survival (Phase II) | The study was suspended prematurely due to halt in drug production and data were not analyzed | Posted | From start of treatment to time of progression or death, whichever occurs first, assessed up to 4 years |
|
|
2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
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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 | Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. | 3 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. | 1 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel | Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2. | 4 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel | Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ascite | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Gait disturbance | General disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Vaginal pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Type II Diabetes | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Gerd | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hearing loss | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Non-systematic Assessment | PE right lung |
| |
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hot flashes | General disorders | Non-systematic Assessment |
| ||
| Edema | Blood and lymphatic system disorders | Non-systematic Assessment | limbs |
| |
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Neck pain | General disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Brittle finger nails | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Oral thrush | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ecchymosis | Injury, poisoning and procedural complications | Non-systematic Assessment | IV site at forearm |
| |
| Jitters | General disorders | Non-systematic Assessment |
| ||
| Bladder pain | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Sweats | General disorders | Non-systematic Assessment |
| ||
| Heart palpitations | Cardiac disorders | Non-systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment | Bleeding |
| |
| Hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Back pain | General disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Muscle aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Rib pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Shakiness | General disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Protocol Development Coordinator | Fox Chase Cancer Center | 215-728-4097 | ryan.romasko@fccc.edu |
| Oct 6, 2020 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D013660 | Taxes |
| C533237 | STA 9090 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Hispanic or Latino |
|