araag2/HINT huggingface dataset:
Clinical trial NCT00615134 (phase 2, status: completed)
Conditions: hiv infections
ICD codes: Z21
Drugs: enfuvirtide [fuzeon], optimized background arv therapy
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(C)=O)[C@@H](C)O)[C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC1=CC=CC=C1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  HIV-1 infection, with virologic failure;

          -  on same stable HAART for >4 weeks, with viral load >1000 RNA copies/mL;

          -  Fuzeon-naive.

        Exclusion Criteria:

          -  coinfection with HIV-2;

          -  active opportunistic infection in 4 weeks prior to screening;

          -  cirrhosis or severe liver failure;

          -  severe renal disease.
Clinical trial NCT00416182 (phase 2, status: completed)
Conditions: sinusitis, cystic fibrosis
ICD codes: J01.80, J01.90, J32.0, J32.1, J32.2, J32.3, J32.8, E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4
Drugs: pulmozyme (dornase alfa), placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Clinical and laboratory diagnosis of cystic fibrosis

          -  Age greater than or equal to 5 years

          -  Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted

          -  Sinus surgery within one week of enrollment

        Exclusion Criteria:

          -  Pregnancy

          -  Intolerance of orally inhaled Pulmozyme (dornase alfa)
Clinical trial NCT01360086 (phase 2, status: completed)
Conditions: adenocarcinoma of the gastroesophageal junction, gastric cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cisplatin, fluorouracil, leucovorin calcium
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

               -  Stage IB, II, or III disease according to TNM classification OR type I, II, or
                  III disease according to Siewert classification

                    -  TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)

               -  Disease considered operable with curative intent

          -  No gastric scirrhous carcinoma (linitis plastica)

               -  Forms with independent cells are not considered linitis

          -  Measurable disease according to RECIST V1.1

          -  No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the
             gastroesophageal junction type I

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Polynuclear neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Creatinine clearance > 50 mL/min

          -  Bilirubin < 1.5 times normal

          -  Serum albumin > 30 g/L

          -  Prothrombin time ≥ 80%

          -  FEV1 > 1 L in case of thoracotomy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known cirrhosis

          -  No other progressive condition that has not been stabilized including the following:

               -  Hepatic failure

               -  Renal failure

               -  Respiratory failure

               -  NYHA class III-IV congestive heart failure

               -  Unstable angina

               -  Myocardial infarction in the past 6 months

               -  Significant arrhythmias in the past 12 months

          -  No recent weight loss exceeding 15%

          -  No interstitial pneumonia

          -  No other malignant tumor within the past 5 years except for basal cell skin carcinoma
             or cancer in situ of the cervix

          -  No psychological, familial, or geographical reasons that will preclude the patient
             being monitored regularly

          -  No persons deprived of liberty or under guardianship (Disability Act)

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy or radiotherapy for gastric cancer

          -  No other concurrent anticancer treatment, immunotherapy, or hormone therapy

          -  No prior abdominal or thoracic radiotherapy
Clinical trial NCT01414101 (phase 2, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: isis crp rx or placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female; age 18 to 75 years

          -  Active RA for at least 6 months

          -  Active disease defined by having equal to or greater than 6 swollen joints and 6
             tender joints, based on a 28 joint count

          -  On stable doses and regimen of allowed RA medications

          -  Currently receiving at least 10 mg of methotrexate a week. Patients unable to tolerate
             doses greater than 10 mg may also be eligible for enrollment.

        Exclusion Criteria:

          -  Diagnosis of Felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic
             disease

          -  Any surgical procedure within 30 days of Screening or likely to need joint or tendon
             surgery or other surgical procedure during the study

          -  Intra-articular or intra-muscular corticosteroids within 60 days prior to dosing

          -  Previous treatment with any biologic response modifying agent for RA within 90 days or
             5 half-lives, whichever is greater, prior to screening

          -  Previous treatment with rituximab at any time

          -  Use of corticosteroid therapy equivalent to an average daily dose of >10 mg of
             prednisone

          -  Any Screening laboratory values that are out of allowed reference ranges

          -  Inability to comply with protocol or study procedures

          -  Any other significant illness or condition that may adversely affect the subjects
             participation in the study
Clinical trial NCT00322348 (phase 2, status: completed)
Conditions: advanced breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: goserelin acetate, goserelin acetate
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed
             oestrogen receptor positive (ER +ve) breast cancer

          -  World Health Organization (WHO) performance status of 0, 1, or 2

          -  Provided written informed consent

        Exclusion Criteria:

          -  Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC)
             adjuvant in the previous 24 weeks

          -  Received radiotherapy within the past 4 weeks

          -  History of systemic malignancy other than breast cancer within the previous 3 years

          -  Estimated survival less than 24 weeks
Clinical trial NCT01203098 (phase 2, status: completed)
Conditions: venous thromboembolism, thromboembolism, thrombosis, embolism and thrombosis, deep vein thrombosis, arthroplasty, replacement, hip
ICD codes: O88.22, O88.23, O88.211, O88.212, O88.213, O88.219, O88.22, O88.23, O88.211, O88.212, O88.213, O88.219, I81, K64.5, I51.3, I67.6, I74.11, I74.5, I74.8, I82.491, I82.492, I82.493, I82.499, I82.591, I82.592, I82.593, Z79.890, Z96.693, Z47.1, Z95.4, Z96.691, Z96.692, T82.320S
Drugs: du-176b 15mg, du-176b 30mg, enoxaparin sodium 20 mg (=2000iu)
SMILES: CN(C)C(=O)[C@H]1CC[C@H](NC(=O)C(=O)NC2=NC=C(Cl)C=C2)[C@@H](C1)NC(=O)C1=NC2=C(CN(C)CC2)S1, CN(C)C(=O)[C@H]1CC[C@H](NC(=O)C(=O)NC2=NC=C(Cl)C=C2)[C@@H](C1)NC(=O)C1=NC2=C(CN(C)CC2)S1, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing unilateral total hip arthroplasty

          2. Patients who are 20-84 years olds

        Exclusion Criteria:

          1. Subjects with risks of hemorrhage

          2. Subjects with thromboembolic risks

          3. Subjects who weigh less than 40 kg

          4. Subjects who are pregnant or suspect pregnancy, or subjects who want to become
             pregnant
Clinical trial NCT01871441 (phase 2, status: terminated)
Conditions: malignant neoplasm
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cyclophosphamide, tacrolimus, mycophenolate mofetil
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    trial was closed due to poor accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Any patient with a hematologic or oncologic diagnosis without morphological evidence
             of disease in which allogeneic HSCT is thought to be beneficial.

          2. Patients must have a related donor who is a two or more allele mismatch at the HLA-A;
             B; C; DR loci.

          3. Patients must have adequate organ function:

               1. LVEF (Left ventricular ejection fraction) of >50%

               2. Diffusion Capacity for Carbon Monoxide (DLCO) >50% of predicted corrected for
                  hemoglobin

               3. Adequate liver function as defined by a serum bilirubin <1.8, Aspartate
                  Aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5X upper limit of
                  normal

               4. Creatinine clearance of > 60 ml/min

          4. Performance status > 80% (TJU Karnofsky)

          5. Hematopoietic Comorbidity Index (HCT-CI) Score < 5 Points

          6. Patients must be willing to use contraception if they have childbearing potential

          7. Able to give informed consent, or if decisionally impaired, have a legal next of kin
             or guardian that can give informed consent

        Exclusion Criteria:

          1. Performance status < 80 % (TJU Karnofsky)

          2. HCT-CI Score > 5 Points

          3. Combination of Performance status of < 80% (TJU Karnofsky) and an HCT-CI of 4 points
             or more.

          4. HIV positive

          5. Active involvement of the central nervous system with malignancy

          6. Psychiatric disorder that would preclude patients from signing an informed consent

          7. Pregnancy

          8. Patients with life expectancy of < 6 months for reasons other than their underlying
             hematologic/oncologic disorder

          9. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or
             who have recently received horse or rabbit anti-thymocyte globulin and have an ATG
             level of > 2 ugm/ml

         10. Patients who cannot receive cyclophosphamide

         11. Patients with evidence of another malignancy, exclusive of a skin cancer that requires
             only local treatment, should not be enrolled on this protocol
Clinical trial NCT00385996 (phase 2, status: completed)
Conditions: carcinoma, non-small cell lung
ICD codes: D02.20, D02.21, D02.22
Drugs: tarceva (erlotinib)
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical
             resection

          -  Ambulatory and capable of all self-care but may be unable to carry out any work
             activities.

          -  Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell
             medical center for purposes of volumetric measurements.

          -  Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.

          -  18 years and older.

          -  Women of child-bearing potential must be taking adequate contraceptive precautions
             prior to study entry and for the duration of study participation. A negative serum or
             urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and
             premenopausal women of child bearing potential will follow an approved, medically
             accepted birth control regimen or agree to abstain from heterosexual intercourse while
             taking study drug and for 30 days following the last dose of study drug.

        Exclusion Criteria:

          -  Cannot be on any other anti-cancer treatment during this study.

          -  Prior treatment with any EGFR inhibitor.

          -  Patients who had prior treatment with chemotherapy or radiation for this disease.

          -  Other active cancers.

          -  Tumors with a mixed histology of small cell and non-small cell carcinoma as well as
             patients with pulmonary carcinoid tumors.

          -  Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel
             disease.

          -  Hypersensitivity to compounds similar in chemical composition to Tarceva®.

          -  Active infection or serious underlying medical conditions which would impair protocol
             treatment.
Clinical trial NCT00301405 (phase 2, status: terminated)
Conditions: chronic prostatitis, pelvic pain
ICD codes: N41.1, R10.2
Drugs: thalidomide
SMILES: CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Reason stopped: 
    study closed. difficult enrollment of patients with prostatitis.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Male subjects aged 18 and older.

          2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to
             other therapies

          3. Subjects with a minimum score of 15 on the CPSI.

          4. Male subjects must give written informed consent.

          5. Male subjects must be willing an able to comply with the most recent version of the
             FDA-mandated S.T.E.P.S.â Program to include:

               -  He understands and can reliably carry out all instructions.

               -  He is capable of complying with the mandatory contraceptive measures that are
                  appropriate for male patient registration, and patient surveys as described in
                  the S.T.E.P.S.â program.

               -  He has received both oral and written warning of the hazards of taking
                  thalidomide and exposing a fetus to the drug

               -  He has received both oral and written warning of the risk of possible
                  contraception failure and of the presence of thalidomide in semen. He has been
                  instructed that he must always use a late condom during any sexual contact with a
                  woman of childbearing potential, even if he has undergone a successful vasectomy.

               -  He acknowledges in writing his understanding of these warning and of the need to
                  use a latex condom during any sexual contact with women of childbearing
                  potential, even if he has undergone a successful vasectomy.

               -  He agrees NOT to be a sperm or blood donor while being treated with thalidomide -

        Exclusion Criteria:

          1. Subjects who are female.

          2. Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past
             six months

          3. Subjects with duration of symptoms less than three months

          4. Subjects with active genital infections

          5. Subjects with prior urologic surgeries

          6. Subjects with known active or prior genitourinary cancers including renal, ureteral,
             bladder or prostate

          7. Subjects having received prior radiation to the abdominal or pelvic area

          8. Subjects with known bladder or ureteral calculi

          9. Subjects unable to complete a voiding diary

         10. Subjects diagnosed with neuropathy

         11. Subjects with neutropenia

         12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or
             hypercoagulable state

         13. Any patient who is not willing to comply with the most recent version of the
             FDA-mandated S.T.E.P.Sâ program

         14. Subjects with orthostatic hypotension

         15. Subjects with known malignancies in the last 2 years.
Clinical trial NCT00396604 (phase 2/phase 3, status: completed)
Conditions: pulmonary disease, chronic obstructive, copd, lung diseases, obstructive
ICD codes: J44.9, J44.1, J44.0, G91.1, I42.1, N11.1, J05.0, G47.33, J44.9, N13.8
Drugs: indacaterol maleate
SMILES: CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Male and females aged 40-75 years with COPD and symptoms such as cough, sputum
             production, and shortness of breath.

          -  Smoking history of at least 10 pack years

          -  FEV1 less than 65% of the predicted normal value and at least 0.75 L

          -  Pre-bronchodilator FEV1/FVC less than 70%

        Exclusion Criteria:

          -  A history of asthma or COPD diagnosis before the age of 40

          -  Hospitalization for COPD exacerbation within the previous 6 weeks

          -  Respiratory tract infection within 6 weeks

          -  Use of long-term oxygen therapy

          -  Diabetes type I or uncontrolled diabetes type II

          -  Clinically relevant laboratory abnormality or clinically significant condition

          -  Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a
             history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may
             apply.
Clinical trial NCT00258765 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: zoledronic acid, docetaxel
SMILES: OC(CN1C=CN=C1)(P(O)(O)=O)P(O)(O)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    poor recruitment & not feasible to continue
  
Eligibility criteria:

        Inclusion Criteria:

          -  Radical prostatectomy for prostate cancer within last 2 months.

          -  Post-operative Kattan nomogram predicts >25% risk of PSA relapse by 5 years.

          -  6-week post-operative serum PSA<0.2ng/mL.

          -  Low levels of circulating prostate cancer cells in the blood, detected by PCR
             amplification of PSA mRNA 6 weeks post-prostatectomy.

        Exclusion Criteria:

          -  Pre-operative serum PSA level >20ng/ml.

          -  Clinical evidence of metastases by 6-week post-operative visit.

          -  Prior treatment with either ADT or bisphosphonate therapy.

          -  Current active dental problems including infection of the teeth or jawbone (maxilla or
             mandibular); dental or fixture trauma, or a current or prior diagnosis of
             osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after
             dental procedures.

          -  Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)

        Other protocol defined inclusion / exclusion criteria may apply.
Clinical trial NCT00434434 (phase 2, status: completed)
Conditions: allergic asthma
ICD codes: D69.0, L50.0, B44.81, J30.89, J30.9, L20.84, H10.45
Drugs: omalizumab, omalizumab, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form

          -  Meet criteria for the diagnosis of allergic asthma

          -  Be between the ages of 18 to 65 years

          -  Have a normal chest X-ray within 2 years of screening

        Exclusion Criteria:

          -  Need daily controller medication for asthma

          -  History of hypersensitivity to the study drug or to drugs with similar chemical
             structures or to any ingredients, including excipients of the study medication or
             drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)

          -  Have a documented medical history of anaphylaxis

          -  Have lung disease other than mild allergic asthma

          -  Have taken other investigational drugs within 30 days or 5 half-lives prior to the
             screening visit, whichever is longer

          -  Are unable or unwilling to comply with study procedures and visits

          -  Are pregnant or lactating

          -  Have significant medical illness other than asthma, including malignancies, parasitic
             infections, immune system disorders, and thrombocytopenia

          -  Have been treated with omalizumab within 12 months prior to screening

          -  Currently smoke or have a history of smoking more than 10 pack-years

          -  Have a history of drug or alcohol abuse, which, in the judgment of the investigator,
             may put the subject at risk for being unable to participate fully in the study for the
             duration of the study
Clinical trial NCT00316199 (phase 2, status: completed)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: gemcitabine, paclitaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Female patients of Chinese origin with histologically or cytologically proven
             diagnosis of breast cancer.

          -  Unresectable, locally recurrent breast cancer or stage IV disease.

          -  Have at least one measurable lesion as defined by Response Evaluation Criteria In
             Solid Tumors (RECIST) criteria.

          -  Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale

          -  Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant
             setting with subsequent disease relapse.

        Exclusion Criteria:

          -  Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic
             disease.

          -  Concurrent administration of any other tumor therapy, including cytotoxic
             chemotherapy, hormonal therapy, and immunotherapy.

          -  Known or suspected brain metastasis or second primary malignancy that is clinically
             detectable at the time of consideration for study enrollment.

          -  Active infection or other serious condition.

          -  Pregnant or breastfeeding.