bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: E7389
Intervention description: Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the
      tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and
      estimate the recommended dose.
    

Eligibility criteria:

        Inclusion Criteria

          -  Females aged greater than or equal to 20 years and less than 75 years at the time of
             informed consent.

          -  Histologically or cytologically confirmed with breast cancer

          -  Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ
             Hybridization (FISH) method

          -  Subjects who meet any of the following criteria:

               -  Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane

               -  Evidence of recurrence within 6 months after adjuvant chemotherapy with
                  trastuzumab and taxane

               -  Experienced prior chemotherapy including trastuzumab and taxane for advanced or
                  recurrent breast cancer

          -  Adequate organ function

          -  Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1

          -  Subjects who have submitted written informed consent for study entry

        Exclusion Criteria

          -  Subjects with known brain metastasis accompanied by clinical symptoms or requiring
             active treatment

          -  Subjects with severe active infection requiring active treatment

          -  Subjects with large pleural effusions, ascites, or pericardial effusions requiring
             drainage.

          -  Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives

          -  Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B
             surface (HBs antigen) or hepatitis C (HCV) by serum test.

          -  Subjects who are pregnant (positive B-hCG test) or breastfeeding

          -  Subjects judged to be ineligible for this study by the principal investigator or
             sub-investigator.
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Condition: Breast Neoplasms; Secondary; HER2 Positive Carcinoma of Breast
MeSH terms: Breast Neoplasms
Intervention: Zr89-trastuzumab
Intervention description: trastuzumab labelled with zirconium 89 for PET/CT
Intervention MeSH terms: Trastuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled
      trastuzumab.
    

Eligibility criteria:

        Inclusion criteria:

          1. All patients selected for this imaging study are patients scheduled to start
             trastuzumab-based therapy for advanced HER2 positive breast cancer (This includes
             trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).

          2. Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than
             2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally
             recurrent or metastatic disease.

          3. Patients with FDG-PET positive metastatic lesions.

          4. Brain metastases are allowed provided they are controlled and they are not the sole
             site of metastatic disease.

          5. Patient planned to have metastatic site biopsy for HER2 status control.

          6. Age ≥ 18 years

          7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1

          8. For women of childbearing potential a pregnancy test will be done and an agreement to
             use a highly-effective non hormonal form of contraception.

          9. Agreement from the patient to participate in this imaging study and if indicated
             agreement to biopsy one or two accessible lesions.

         10. Signed written informed consent (approved by the Ethics Committee) obtained prior to
             any study procedure

        Exclusion criteria:

          1. Current severe, uncontrolled systemic disease (e.g., clinically significant
             cardiovascular, pulmonary, or metabolic disease)

          2. Pregnant or lactating women

          3. Current known infection with HIV, HBV, or HCV

          4. Known severe hypersensitivity to trastuzumab

          5. Assessed by the investigator to be unable or unwilling to comply with the requirements
             of the protocol

          6. Patients with bone only metastases are not eligible

          7. Psychiatric illness/social situations that would limit compliance with study
             requirements

          8. Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
Condition: Cancer of Kidney; Kidney Cancer; Renal Cancer; Neoplasms, Kidney; Renal Neoplasms; Renal Cell Carcinoma (RCC); Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Neoplasms; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: 124-Iodine-cG250 (124I-cG250)
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Cancer; Renal Cancer; Neoplasms, Kidney; cG250; antibody; Iodine 124

Summary:

      The purpose of this study is to see if an antibody (cG250) attached to a radioactive
      substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors
      scheduled for surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presence of a renal mass.

          2. Scheduled for surgical resection of renal mass.

          3. Expected survival of at least 3 months.

          4. Karnofsky performance scale ≥70.

          5. The following laboratory results should be within the following limits within the last
             4 weeks prior to study day 1:

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L

               -  Platelet count ≥ 100 x 10E9/L

               -  Serum bilirubin ≤ 2.0 mg/dL

               -  Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)

               -  Alanine aminotransferase (ALT) ≤ 2.5 x ULN

               -  Serum creatinine ≤ 2.0 mg/dL

          6. Pregnancy Test to be performed on female patients of childbearing potential within
             24-48 hours before administration of radioactive material.

          7. Recovered from toxicity of any prior therapy.

          8. Able and willing to give valid written informed consent.

        Exclusion Criteria:

          1. Intercurrent medical condition that may limit the amount of antibody to be
             administered.

          2. Intercurrent medical condition that renders the patient ineligible for surgery.

          3. New York Heart Association Class III/IV cardiac disease.

          4. History of autoimmune hepatitis.

          5. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250
             dose.

          6. Mental impairment that may compromise the ability to give informed consent and comply
             with the requirements of the study.

          7. Lack of availability for immunological and clinical follow-up assessments.

          8. Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to enrollment.

          9. Women who are pregnant or breastfeeding.

         10. Allergy to iodine.
PF-06671008 Dose Escalation Study in Advanced Solid Tumors
Condition: Neoplasms
MeSH terms: Neoplasms
Intervention: PF-06671008; PF-06671008
Intervention description: Dose Escalation Phase - Part 1; Dose Expansion Phase - Part 2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: P-cadherin; PF-06671008; solid tumors; lung cancer; breast cancer; colorectal cancer; NSCLC; TNBC; CRC; neoplasms; Triple negative breast cancer; Non-small cell lung cancer

Summary:

      The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
      of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin
      expression. The study will then expand to look at the selected dose in patients with
      P-cadherin expressing TNBC, CRC or NSCLC.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Diagnosis of tumor type with the potential to have P-cadherin expression that is
             resistant to standard therapy or for which no standard therapy is available

          -  Performance status of 0 or 1

          -  Adequate bone marrow, kidney and liver function

        Key Exclusion Criteria

          -  Known CNS disease including, but not limited to, metastases

          -  Current or history of seizure disorder

          -  History of or active autoimmune disorders

          -  Active bacterial, fungal or viral infection

          -  Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study
             treatment

          -  Requirement for systemic immune suppressive medication

          -  Grade 2 or greater peripheral neuropathy
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
Condition: Fungal Infections
MeSH terms: Mycoses
Intervention: Posaconazole 12 mg/kg/day BID; Posaconazole 18 mg/kg/day BID; Posaconazole 18 mg/kg/day TID; Posaconazole 12 mg/kg/day TID
Intervention description: Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day); Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day); Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day); Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)
Intervention MeSH terms: Posaconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 3 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and
      tolerability of oral posaconazole in immunocompromised children with neutropenia or expected
      neutropenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented or anticipated neutropenia expected to last at least 7 days and only in the
             following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia;
             autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk
             neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT
             during the pre-engraftment (neutropenia) period

          -  Participants of child-bearing potential must use a medically accepted method of

        contraception throughout the study and for at least 30 days after stopping study
        medication, unless they are surgically or medically sterile or agree to remain abstinent.

        Exclusion Criteria:

          -  Proven invasive fungal infection (IFI) before study entry

          -  Severe nausea and/or vomiting at screening

          -  Received posaconazole within 10 days before screening

          -  Unable to receive study drug by mouth or via an intestinal (enteral) tube

          -  Females who are pregnant, intend to become pregnant during the study, or are
             breastfeeding

          -  History of anaphylaxis attributed to the azole class of antifungal agents
Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Dasatinib; Capecitabine
Intervention description: Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression; Tablets, Oral, 660 - 1250 mg/m^2 twice a day (BID). Treatment may continue until disease progression.
Intervention MeSH terms: Capecitabine; Dasatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn about the safety and efficacy of Dasatinib in
      combination with Capecitabine for patients with advanced breast cancer, and who have received
      treatment with a taxane and an anthracycline
    

Eligibility criteria:

        For additional information, please contact the BMS oncology clinical trial information
        service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
        www.BMSStudyConnect.com for more information on clinical trial participation.

        Inclusion Criteria:

          -  Female with advanced breast cancer previously treated with a taxane and an
             anthracycline

          -  No pleural or pericardial effusion

          -  Not receiving anticoagulants
Pharmacokinetics of Faldaprevir of Soft Capsule
Condition: Healthy
Intervention: faldaprevir(high dose); Faldaprevir(low dose)
Intervention description: faldaprevir(high dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to high dose treatment in random order; faldaprevir(low dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to low dose treatment in random order
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single
      oral dose and multiple oral doses in Chinese subjects
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male and female subjects

        Exclusion criteria:

        Any relevant deviation from healthy conditionsAny relevant deviation from healthy
        conditions
The Effect of Acute Lysine Administration on α-aminoadipic Acid (Sub-study)
Condition: Healthy
Intervention: C-13 labeled Lysine; Normal saline
Intervention description: Carbon-13 is a stable naturally occurring heavy isotope of carbon. Inclusion of a 13C label on lysine allows for subsequent differentiation between endogenous and exogenous lysine and 2-AAA for calculation of clearance and excretion of the lysine bolus.; Because patients will have multiple blood draws during the course of the study, subjects will have an IV placed to reduce the number of needle sticks. To keep the vein open for blood collections, we will infuse Normal (0.9%) Saline (NS) at a rate of approximately 10ml/hr in order to keep the line open.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This sub-study aims to assess the effect and breakdown of lysine administration, specifically
      examining whether it leads to increased plasma 2-AAA in healthy humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI 18 to <25 kg/m2

          -  Men and women ages 18-45 years

        Exclusion Criteria:

          -  Current use of prescription medications (apart from hormonal birth control)

          -  Current use of amino acid supplements (including branched-chain amino acids) or
             supplemental protein (habitual consumption of protein powder, bars, shakes), and
             unwilling to temporarily discontinue use (1 week prior to study visit)

          -  Individuals who currently use tobacco products or have done so in the previous 30 days

          -  Prior or current cardiovascular disease, renal disease, or liver disease

          -  Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled)

          -  Atrial fibrillation

          -  Bleeding disorder or anemia

          -  Positive pregnancy test

          -  Women who are breastfeeding

          -  Participation in another clinical trial within the previous 6 weeks prior to the study
             visit

          -  Inability to provide written informed consent

          -  Inability to fast for 8 hours
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Condition: Transplant Rejection; Renal Transplantation
Intervention: Sirolimus
Intervention description: Sirolimus, 1 mg, white, triangular tablets, daily dose, dosages of any of these medications must be stable for at least 2 weeks prior to screening and continue with no change until completion of the last PK sample collection.
Intervention MeSH terms: Sirolimus
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Organ Transplants; Anti-Rejection Therapy; Pharmacokinetics

Summary:

      Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China
      for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to
      be conducted in renal allograft recipients was requested by State Food and Drug
      Administration (SFDA) to provide further guidance for clinical use.

      To minimize risk to patients, this study is designed to collect blood PK samples from renal
      allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or
      without concomitant medication(s). PK samples will be collected from these patients to
      characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This
      study will not involve any changes to the established treatment regimen for the patients who
      enroll in the study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, above 18 years of age and Body Mass Index (BMI) of 18.0 to 25.0 kg/m2,
             inclusive;

          -  Subjects must have received a primary or secondary renal allograft for at least 2
             months prior to Screening;

          -  Subjects must be currently taking Rapamune tablets for prophylaxis of renal rejection.
             The dosages of any medications must be stable for at least 2 weeks prior to screening
             and continue with no change until completion of the last PK sample collection.

        Exclusion Criteria:

          -  Acute rejection or vascular rejection episode in the 4 weeks prior to Screening; or
             patients dependent on dialysis; or inadequate renal function (in the opinion of the
             investigator);

          -  Recipients of multiple organ transplants (i.e., prior or concurrent transplantation of
             any organs other than renal transplant);

          -  Current use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to
             collection of the first PK sample and until collection of the final PK sample;

          -  Any clinically significant medical or psychiatric condition or laboratory abnormality,
             in the judgment of the investigator.
ATX Study:A Study of Avastin (Bevacizumab), Tarceva (Erlotinib) and Xeloda (Capecitabine) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: bevacizumab [Avastin]; capecitabine [Xeloda]; erlotinib [Tarceva]
Intervention description: Escalating doses of 5/10mg/kg q2w; Escalating doses of 500/650/750/900mg/m2 bid; Escalating doses of 100/150mg daily
Intervention MeSH terms: Bevacizumab; Capecitabine; Erlotinib Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva
      and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic
      pancreatic cancer. In the first part of the study, cohorts of patients will receive
      escalating doses of combination treatment to determine the maximum tolerated dose. The
      recommended dose will be used in the second part of the study to determine the efficacy of
      the ATX regime, in terms of its effect on disease progression. The anticipated time on study
      treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  pancreatic cancer with locally advanced and/or metastatic disease (stage IV);

          -  chemonaive for metastatic or locally advanced disease;

          -  ECOG performance status of 0-2.

        Exclusion Criteria:

          -  local (stage IA to IIB)and locally advanced (stage III) pancreatic cancer;

          -  previous exposure to Avastin, Tarceva or Xeloda;

          -  other primary tumor within the last 5 years prior to enrollment, except for adequately
             treated cancer in situ of cervix, or basal cell skin cancer;

          -  current or recent chronic use of aspirin (>325 mg/day) or full therapeutic dose of
             anticoagulants or thrombolytic agents.