bioihbjkbjnl/mcl2 huggingface dataset:
A Multiple-Dose Study of RhuMab 2C4 and Docetaxel in the Treatment of Advanced Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: Docetaxel; RhuMab 2C4
Intervention description: Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.; Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.
Intervention MeSH terms: Docetaxel; Pertuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of
      rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that
      have progressed during or after standard therapy, or for which no standard therapy is
      available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in
      escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults at least 18 years of age

          -  Easter Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Life expectancy at least 12 weeks

          -  Locally advanced or metastatic solid tumor with at least 1 measurable lesion, which
             has progressed during/after standard therapy

          -  Human epidermal growth factor receptor 2 (HER2)-negative among participants with
             breast cancer

          -  Negative pregnancy test or use of an adequate contraceptive method among women of
             childbearing potential

          -  Adequate hematologic, hepatic, and renal function

          -  Signed informed consent, histologically or cytologicall confirmed advanced solid
             tumor, adequate cardiac function as documented by LVEF >50% by ECHO or MUGA

        Exclusion Criteria:

          -  Clinical evidence of central nervous system (CNS) metastases

          -  Prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy
             within 2 weeks of study Day 1

          -  History of neuropathy Grade 2 or worse, or any unresolved residual chemotherapy
             effects

          -  Prior HER2-active agents or docetaxel

          -  Any investigational agent within 28 days of study drug

          -  Prior cumulative doxorubicin dose greater than (>) 360 mg/m^2 or equivalent

          -  Significant cardiovascular disease

          -  Active/uncontrolled concurrent illness or infection-

          -  Major surgery or trauma within 4 weeks of study Day 1
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Condition: Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Intervention: Sodium Oxybate (Xyrem)
Intervention description: Active Substance: Sodium Oxybate
Pharmaceutical form: Oral Solution
Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
Route of administration: Oral
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Endocrine Evaluation cataplexy; sodium oxybate (xyrem)

Summary:

      To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus
      on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine
      changes.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Narcoleptic patients with cataplexy

        Exclusion Criteria:

          -  Subjects not diagnosed with narcolepsy with cataplexy

        Exclusion Criteria:
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Condition: Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: denileukin diftitox (E7777)
Intervention description: E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion.
Intervention MeSH terms: Denileukin diftitox
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Neoplasms; Neoplasms by Histologic Type; Lymphoma; Non-Hodgkin; T- Cell; Lymphatic Diseases; Lymphoproliferative Disorders; lmmune System Diseases; lmmunoproliferative Disorders

Summary:

      The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through
      observation of dose limiting toxicity (DLT), which is in advance defined, in patients with
      peripheral or cutaneous T-cell lymphoma.
    

Eligibility criteria:

        lnclusion Criteria:

          -  Male and female patients 20 to less than 80 years of age at the time of informed
             consent

          -  Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma

          -  Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in
             relapse, recurrence and treatment resistance (just for the administration of E7777
             alone)

          -  Patients subject to CHOP therapy and without a history of prior treatment with
             anthracycline or anthraquinone anticancer drugs (just for the administration of E7777
             in combination with CHOP therapy)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

          -  No carry-over of beneficial or adverse effects of the prior treatment that may affect
             the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and
             alopecia)

        Exclusion Criteria:

          -  Brain metastasis with clinical symptoms which requires treatment

          -  Serious systemic infection requiring intensive treatment

          -  Serious complications or histories

          -  History of hypersensitivity to protein therapeutics

          -  Known to be positive for HIV antibody, HCV antibody, or HBs antigen

          -  History of malignancy other than peripheral T-cell lymphoma and less than five years
             have elapsed since the last remission

          -  Patients who have undergone allogeneic hematopoietic stem cell transplantation

          -  Patients with a relapse within 6 months after autologous hematopoietic stem-cell
             transplantation
Phase 1 Trial of Oral Ixabepilone
Condition: Advanced Solid Tumors
Intervention: Ixabepilone (oral formulation)
Intervention description: Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21
      days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and
      safety of this dosing schedule in participants with advanced cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 or older

          -  Histologically or cytologically confirmed diagnosis of solid tumor malignancy

          -  Measurable or non-measurable disease as defined by Response Evaluation Criteria In
             Solid Tumors (RECIST) criteria

          -  Karnofsky Performance Status (KPS) of 70-100

          -  Recovered from toxicities resulting from previous therapies

        Exclusion Criteria:

          -  More than 3 prior cytotoxic regimens in the metastatic setting

          -  Current or recent gastrointestinal (GI) disease that would impact the absorption of
             study drug

          -  Inability to swallow whole capsules

          -  Inadequate hepatic and renal function

          -  Function exposure to any epothilone
Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Sunitinib (Sutent); Taxotere
Intervention description: Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision; Taxotere 75 mg/m2 iv, once every 3 weeks
Intervention MeSH terms: Docetaxel; Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced; sunitinib (Sutent); docetaxel; Phase 1B

Summary:

      This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with
      docetaxel in patients with metastatic or locally recurrent breast cancer who have not
      received chemotherapy treatment in the advanced disease setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast cancer with evidence of unresectable, locally recurrent or metastatic disease

          -  Candidate for treatment with docetaxel

        Exclusion Criteria:

          -  Prior chemotherapy in the advanced disease setting

          -  Inflammatory breast cancer

          -  HER2 positive disease
Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
Condition: Healthy
Intervention: Placebo; PG-760564; PG-760564; PG-760564; PG-760564
Intervention description: oral capsule, 2x/day for 14 days; oral capsule, 50 mg, 2x/day for 14 days; oral capsule, 100mg, 2x/day for 14 days; oral capsule, 200 mg, 2x/day for 14 days; oral capsule, 400 mg, 2x/day for 14 days
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      This study is a multiple ascending dose study to Assess the Safety, Tolerability, and
      Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and
      Female Volunteers for 14 Days (27 Doses).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and surgically sterile or post-menopausal (last menstrual period > 1
             year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at
             screening;

          -  Who have not used tobacco or nicotine-containing products within the past 3 months;

          -  Willing to abstain from caffeine or xanthine-containing beverages, including coffee
             and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours
             before admission and for the duration of the study;

          -  Who have a body mass index (BMI) between 18 and 32 kg/m2.

        Exclusion Criteria:

          -  History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;

          -  History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and
             cholecystectomy are allowed), or GI bleeding;

          -  History of autoimmune disease;

          -  History of immunodeficiency or of unusual susceptibility to infectious diseases;

          -  History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with
             human immunodeficiency virus (HIV);

          -  Any history of hypersensitivity or clinically significant allergy to any drug;

          -  Personal or family history of prolonged QT syndrome or any cardiac conduction
             abnormality;

          -  Family history of sudden death;

          -  History of uveitis or inflammatory ocular disease
Renal Impairment Study of PF-06700841
Condition: Healthy Volunteer; Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: PF-06700841
Intervention description: A single dose of 30 mg PF-06700841 will be administered on Day 1
Intervention MeSH terms: PF-06700841
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single group
Masking: None (Open Label)
Masking description: No Masking
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to characterize the effect of kidney impairment on the blood
      concentrations of PF-06700841 and its major metabolite. Findings from this study will be used
      to develop dosing recommendations so that the dose and/or dosing interval may be adjusted
      appropriately in the presence of kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants who are between the ages of 18 and 75 years, inclusive, at
             the Screening visit.

          -  Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg.

          -  Normal, Severe, Moderate and Mild renal function at 2 Screening visits.

          -  Stable drug regimen

        Exclusion Criteria:

          -  Renal transplant recipients.

          -  Urinary incontinence without catheterization.

          -  Subjects with clinically significant infections within the past 6 months prior to
             first dose of study drug, evidence of active or chronic infection requiring oral
             treatment within 4 weeks prior to first dose

          -  Known history of pulmonary embolism or recurrent deep vein thrombosis

          -  Any condition possibly affecting drug absorption (eg, prior bariatric surgery,
             gastrectomy, ileal resection).
Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: CP-751,871; Cisplatin; Gemcitabine; Pemetrexed
Intervention description: CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year).; Cisplatin 75* mg/m2 or 80* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles.
* 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine; Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles; Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1
      Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the
      anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of
      CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin
      chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven diagnosis of Stage IIIB (N3 and/or T4) or Stage
             IV Non-Small Cell Lung Cancer in patients 18-year-old or older, with Eastern
             Cooperative Oncology Group (ECOG) performance status of 0 or 1 not amenable to
             curative surgery or radiation therapy and an adequate organ function (bone marrow,
             hepatic, renal, and cardiac) within 14 days prior to enrollment.

        Exclusion Criteria:

          -  Any prior treatment for Non-Small Cell Lung Cancer including chemotherapy, biologic
             response modifiers or therapy with any investigational agents.

          -  Patients with known brain metastases, spinal cord compression, uncontrolled superior
             vein cava syndrome or carcinomatous meningitis.

          -  Patients with gastrointestinal abnormalities including active gastrointestinal
             bleeding, pre-diabetes (pre-fasting glycemia > 120 g/dL and/or glycosylate haemoglobin
             level > 7.5%), known HIV or AIDS-related illness, significant active cardiac disease
             or receiving chronic steroid therapy or concurrent use of growth hormones or growth
             hormone inhibitors or aminoglycoside antibiotics should be excluded from the study.
Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy
Condition: Vitrectomy
Intervention: 400 µg Brimonidine Tartrate Implant; 200 µg Brimonidine Tartrate Implant
Intervention description: 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).; 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal
      administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery
      System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plan on having a pars plana vitrectomy for repair of a posterior segment condition
             (eg, epiretinal membrane, macular hole, vitreomacular traction)

          -  Visual acuity in the non-study eye better than 20/200

        Exclusion Criteria:

          -  History of pars plana vitrectomy or retinal detachment surgery in the study eye

          -  Surgery or laser treatment in the study eye within 3 months

          -  Use of brimonidine, apraclonidine or other topical alpha-2-agonist in either eye
             within 2 weeks

          -  Intraocular infection or inflammation
Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Erlotinib; Erlotinib; PF-02341066
Intervention description: Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only); For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2; For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2
Intervention MeSH terms: Erlotinib Hydrochloride; Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Neoplasms; Crizotinib

Summary:

      This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone
      versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell
      lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally
             advanced or metastatic and of the adenocarcinoma subtype (including mixed
             adenosquamous histology)

          -  evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST)
             after at least one but no more than 2 chemotherapy regimens for advanced disease

          -  tumors must have measurable disease as per RECIST

        Exclusion Criteria:

          -  known interstitial lung disease

          -  prior treatment with an agent that is known or proposed to be active by action on EGFR
             tyrosine kinase or c-Met/HGF (Phase 2 Portion)