anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Letrozole
Trial phase: Phase 2
ATC code: L02BG04
SMILES: N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Letrozole, 2.5 mg daily for six months
Eligibility criteria:
Inclusion Criteria:

evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
on hormone replacement therapy
postmenopausal
increased risk of developing breast cancer based on personal or family history
never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
women who have a high risk of breast cancer
older than 18 years

Exclusion Criteria:

anticoagulants
marked breast tenderness
pregnant or within twelve months of breast feeding/childbirth
Intervention: Tasimelteon
Trial phase: Phase 3
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: 20 mg taken orally 30 minutes prior to bedtime.
Eligibility criteria:
Inclusion Criteria:

Healthy subjects with no medical, psychiatric or current sleep disorders.
Subject must sign a written consent form.

Exclusion Criteria:

Recent history of night shift work or jet lag.
Prior experience sleeping in a sleep lab environment.
History of sleep disorders.
Intervention: Tasimelteon
Trial phase: Phase 3
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 102
Group description: 50 mg taken orally 30 minutes prior to bedtime.
Eligibility criteria:
Inclusion Criteria:

Healthy subjects with no medical, psychiatric or current sleep disorders.
Subject must sign a written consent form.

Exclusion Criteria:

Recent history of night shift work or jet lag.
Prior experience sleeping in a sleep lab environment.
History of sleep disorders.
Intervention: Tasimelteon
Trial phase: Phase 3
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 106
Group description: 100 mg taken orally 30 minutes prior to bedtime.
Eligibility criteria:
Inclusion Criteria:

Healthy subjects with no medical, psychiatric or current sleep disorders.
Subject must sign a written consent form.

Exclusion Criteria:

Recent history of night shift work or jet lag.
Prior experience sleeping in a sleep lab environment.
History of sleep disorders.
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Randomized to receive celecoxib daily for 12 months
Eligibility criteria:
Inclusion Criteria:

women who have a high risk of breast cancer
older than 18 years

Exclusion Criteria:

anticoagulants
marked breast tenderness
pregnant or within twelve months of breast feeding/childbirth
Intervention: Paroxetine
Trial phase: Phase 4
ATC code: N06AB05
SMILES: Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.

Open Label (OL) Paroxetine: Open-label Paroxetine
Eligibility criteria:
Inclusion Criteria:

Veteran age 18 to 75.
Competent to give informed consent.
Meeting DSM-IV criteria for PTSD.
Minimal CAPS score of 50 at baseline.
If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.

Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine [5 weeks])

monoamine oxidase inhibitors (MAOIs [4 weeks])
depot neuroleptics [4 weeks])
or any investigational drug within 30 days prior to study enrollment.

To be eligible for Phase II

patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8
must have PTSD symptoms at least moderate severity on CGI-S
and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.

Exclusion Criteria:

History of sensitivity to paroxetine or quetiapine.
Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).

Women who are

breast-feeding
pregnant
expect to become pregnant during the course of the study
or are sexually active and are not using a medically acceptable method of birth control.

Presence of clinically significant hepatic

cardiovascular
or other medical conditions that may prevent safe administration of paroxetine or quetiapine
or any other clinically significant unstable medical conditions.
Intervention: Lamotrigine
Trial phase: Phase 3
ATC code: N03AX09
SMILES: Nc1nnc(-c2cccc(Cl)c2Cl)c(N)n1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: once daily orally for 16 weeks
Eligibility criteria:
Inclusion criteria:

Subjects must sign and date the informed consent form
Clinical diagnosis as refractory epilepsy

Exclusion criteria:

Progressive neurologic disease
Serious psychiatric disease
Hemolytic anemia
G6PD (glucose-6-phosphate dehydrogenase) deficiency
Acute intermittent porphyrias
Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past
Drug or alcohol addiction
Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST > 2x ULN)
Stevens-Johnson syndrome
Progressive exfoliative dermatitis
Pregnant, lactating or of childbearing potential female
Regularly taking oral contraceptives
Hypersensitivity to study drugs
Severe cardiac disease (New York Heart Association Functional Class III and IV)

History of malignancy within 5 years

Taking valproic acid within 7 days prior to screening
Subjects with simple partial seizures without motor component
Intervention: Qlaira
Trial phase: Phase 3
SMILES: CC12CCC3=C4CCC(=O)C=C4CCC3C1CCC2(O)CC#N.CCCCC(=O)OC1CCC2C3CCc4cc(O)ccc4C3CCC12C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
Eligibility criteria:
Inclusion Criteria:

Women 18 years or older
With diagnosis of dysfunctional uterine bleeding without organic pathology
And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding

Exclusion Criteria:

The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.
Intervention: Platinum
Trial phase: Not Applicable
SMILES: [Pt]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.
Patients must have signed an informed consent

Exclusion Criteria:

Previous cancer other than skin cancer
Previous chemotherapy experience
Active substance abuse
Schizophrenia
Pregnant or lactating
Intervention: Pemetrexed
Trial phase: Phase 2
ATC code: L01BA04
SMILES: Nc1nc(=O)c2c(CCc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)c[nH]c2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Eligibility criteria:
Inclusion Criteria:

Advanced, metastatic, or recurrent head and neck cancers
Poor risk patients with ECOG performance status of 2

Exclusion Criteria:

Prior treatment for recurrent or metastatic disease
No clinical or radiological evidence of brain metatases
Patients with bone only disease are not eligible
Patients with pleural or peritoneal effusion as only manifestation of diesase
Intervention: Prednisolone
Trial phase: Phase 3
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Drug: prednisone alone protocol

prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.
Eligibility criteria:
Inclusion Criteria:

Male and female MG patients age greater than 18 and less than 65 years
Onset of generalized MG within the last 5 years
Positive serum anti-acetylcholine receptor binding antibodies (muscle acetylcholine receptors, AchRAb =/> 1.00 nmol/L. AchRAb levels of 0.50-0.99 nmol/L will be acceptable if there is another confirmatory test for MG, including single-fiber electromyography (EMG), repetitive nerve stimulation, or unequivocal edrophonium testing.)
MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone

Exclusion Criteria:

Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids
Myasthenic weakness requiring intubation (MGFA Class IV) in the prior month
Immunosuppressive therapy other than corticosteroids in the preceding year
Medically unfit for thymectomy
Chest CT evidence of thymoma.
Pregnancy or lactation; contraindications to the use of corticosteroids, unless postmenopausal or surgically sterile. Women considering becoming pregnant during the period of the study are to be excluded.
A serious concurrent medical, neurological or psychiatric condition that would interfere with thymectomy or subsequent clinical assessments
Current alternate day dose of prednisone > than 1.5 mg/kg or 100 mg or the equivalent daily doses (> 0.75 mg/kg or 50 mg).
Participation in another experimental clinical trial
History of alcohol or drug abuse within the 2 years prior to randomization.
Intervention: Cetirizine
Trial phase: Phase 4
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 157
Group description: 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
Eligibility criteria:
Inclusion Criteria:

Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
Have used forbidden concomitant medications as defined by the protocol
Intervention: Montelukast
Trial phase: Phase 4
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 156
Group description: 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Eligibility criteria:
Inclusion Criteria:

Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
Have used forbidden concomitant medications as defined by the protocol
Intervention: Leuprolide Acetate
Trial phase: Phase 3
SMILES: CC(=O)O.CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 201
Group description: Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Eligibility criteria:
Main Inclusion Criteria:

Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
Baseline testosterone >1.5 ng/mL.
Life expectancy of at least 12 months.
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 769
Group description: 500 mcg, once daily, oral administration in the morning
Eligibility criteria:
Main Inclusion Criteria:

COPD patients having at least one exacerbation within last year
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

COPD exacerbation not resolved at first baseline visit
Diagnosis of asthma and/or other relevant lung disease
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 778
Group description: 500 mcg, once daily, oral administration in the morning
Eligibility criteria:
Main Inclusion Criteria:

COPD patients having at least one exacerbation within last year
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

COPD exacerbation not resolved at first baseline visit
Diagnosis of asthma and/or other relevant lung disease
Intervention: Pramipexole
Trial phase: Phase 4
ATC code: N04BC05
SMILES: CCCN[C@@H]1CCc2nc(N)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
Eligibility criteria:
Inclusion Criteria:

15-item Geriatric Depression Scale (GDS) > or = 5
Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 > or = 2
Folsteins Mini-Mental State Examination (MMSE) score > 24
Male or female patient with PD (UK PD Brain Bank criteria).
Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms .
Male or female patients aged 30 - 80 years.
Ability to provide written informed consent.
Women of childbearing potential must have a negative serum beta-humanchoriongonadotropin (Beta-HCG) pregnancy test at the Screening visit unless surgically sterile or last menstruation >or = 12 months prior to signing informed consent.
Women of childbearing potential must be using an accepted contraceptive.
Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients.
History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential.
Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
History of PD stereotactic brain surgery.
Surgery within 180 days of randomization that would negatively impact the patients participation in the study.
History of active epilepsy within the past year.
Current psychotherapy or behavior therapy while participating the trial
Symptomatic orthostatic hypotension prior to randomization.
Malignant melanoma or history of previously treated malignant melanoma.
Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3 months.
Patients who have received dopamine agonists within the past 30 days
Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1).
Patients who are currently lactating.
Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization.
Any other laboratory assay abnormality, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
Any other clinically significant medical/psychiatric condition, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
Intervention: Lumefantrine co-artemether
Trial phase: Phase 3
SMILES: CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1/C2=C/c1ccc(Cl)cc1.[H][C@]12O[C@H](OC)[C@H](C)[C@]3([H])CC[C@@H](C)[C@]4([H])CC[C@](C)(OO[C@]143)O2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 204
Group description: Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days.
Eligibility criteria:
Inclusion criteria:

children aged 6-120 months;
axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;
P. falciparum asexual parasitemia between 1000 and 100000/µl;
ability to attend follow-up visits.

Exclusion criteria:

co-infections;
underlying chronic disease;
severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml), respiratory distress, inability to drink, persistent vomiting in past 24 hours;
recent history of multiple convulsions;
jaundice;
the inability to stand or sit;
history of allergy to study drugs.
Intervention: Winthrop
Trial phase: Phase 3
ATC code: P01BF03
SMILES: CC1CCC2C(C)C(OC(=O)CCC(=O)O)OC3OC4(C)CCC1C32OO4.CCN(CC)Cc1cc(Nc2ccnc3cc(Cl)ccc23)ccc1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 612
Group description: Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days.
Eligibility criteria:
Inclusion criteria:

children aged 6-120 months;
axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;
P. falciparum asexual parasitemia between 1000 and 100000/µl;
ability to attend follow-up visits.

Exclusion criteria:

co-infections;
underlying chronic disease;
severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml), respiratory distress, inability to drink, persistent vomiting in past 24 hours;
recent history of multiple convulsions;
jaundice;
the inability to stand or sit;
history of allergy to study drugs.
Intervention: Tacrolimus
Trial phase: Phase 4
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
Eligibility criteria:
Inclusion Criteria:

Adult (at least 18 years old)
Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites
Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients

Exclusion Criteria:

Age less than 18
Inability to provide proper informed consent
Combined organ transplantation
Re-Transplantation
Intervention: Sunitinib
Trial phase: Phase 2
ATC code: L01EX01
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(F)cc32)c1C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Sunitinib
Eligibility criteria:
Inclusion Criteria:

Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
Adenocarcinoma of the prostate
Male subjects, 18 years of age or older
Life expectancy of > 12 weeks
Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedure to National Cancer Institute Common Toxicity Criteria Adverse Event (NCI CTCAE) grade <1
Surgical or ongoing chemical castration
Androgen-independent disease, defined as progressive disease despite surgical or ongoing chemical castration. See section 8.2.3 for definition of progressive disease.
Eastern Cooperative Oncology Group performance status of 0, 1 or 2

Adequate bone marrow reserve:

Neutrophil count > 1,500/ul
Platelet count > 75,000/ul

Adequate hepatic function:

Serum bilirubin < 1.5 x upper limit of normal
Asparate aminotransferase and alanine aminotransferase < 2.5 x upper limit of normal
Adequate renal function, with serum creatinine < 2 x upper limit of normal
Prostate Specific Antigen (PSA) > 5.0 ng/mL, based on PSA Working Group Criteria
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

For Group A only:

· No prior treatment for prostate cancer with cytotoxic chemotherapy

For Group B only:

Radiographic evidence of metastatic prostate cancer
One prior docetaxel-based chemotherapy regimen, minimum of two cycles
Disease progression during treatment with docetaxel, or within 60 days of receiving docetaxel

Exclusion Criteria:

Small cell carcinoma of the prostate
Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.
Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident
Receipt of any investigational anti-cancer agent within 4 weeks of the study
NCI CTCAE grade 3 hemorrhage < 4 weeks of starting study treatment
Uncontrolled hypertension
Prolongation of the QTc interval to > 450 msec
Other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.