Use of other investigational agents from 30 days prior to the Screening Visit through discontinuation of study drug.
Subjects with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at the Screening Visit, the following criteria are met:
documented as surgically sterilized (at least 1 month prior to the screening visit)
Are postmenopausal for at least 1 year before the screening visit, OR
Platelets >= 75 x 10^9/L, at the screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Creatinine (Cr) > 2 mg/dL at the screening visit
Hemoglobin < 9 g/dL at the screening visit at the screening visit
Creatinine (Cr) > 2 mg/dL at the screening visit
Withdrawal from the OPN-305-106 study prior to the final EOT visit
Subjects with a platelet count of at least 100 x 10^9 at the screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Age ?18 years at the screening visit.
Subjects with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management within 2 weeks of the screening/enrollment visit
Are postmenopausal for at least 1 year before the screening visit, or
Are at least age 18 at screening (Visit 1)
Locoregional treatment within 4 weeks prior to the Baseline Visit.
INCLUSION CRITERIA\n\n          1. Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.\n\n          2. Patient has SCD, including HbSS, HbSC, HbS?0-thalassemia, or HbS?+-thalassemia,\n             documented in their medical history.\n\n          3. If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable\n             regimen.\n\n          4. Per medical history and/or patient recall, patient has had at least 1 and no more than\n             10 sickle cell-related pain crises in the 12 months before the Screening Visit and\n             none occurring in the 4 weeks before the Randomization Visit.\n\n          5. Patient completes daily eDiary entries for at least 10 days during the last 14 days of\n             the Run in Period as assessed at the Randomization Visit.\n\n          6. Women of childbearing potential must have a negative pregnancy test prior to\n             randomization and must agree to use protocol-specified contraception from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n          7. Male patients must be surgically sterile by vasectomy (conducted ?60 days before the\n             Screening Visit or confirmed via sperm analysis) or must agree to use\n             protocol-specified contraception and agree to refrain from sperm donation from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n        EXCLUSION CRITERIA\n\n          1. Patient requires a program of prescheduled, regularly administered chronic blood\n             transfusion therapy.\n\n          2. Patient has been hospitalized for an SCD-related complication in the 4 weeks before\n             the Randomization Visit.\n\n          3. Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before\n             the Randomization Visit.\n\n          4. Patient is taking aspirin ?325 mg daily, P2Y12 inhibitors, any anticoagulant\n             medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors\n             of PDE5, moderate or strong cytochrome P450 3A (CYP3A) inhibitors, any supplements for\n             the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors\n             in any form.\n\n          5. Patient has major concurrent illness or medical condition that in the opinion of the\n             Investigator would preclude participation in a clinical study.\n\n        NOTE: Other inclusion and exclusion criteria apply, per protocol
Age ?18 years at the screening visit.
Haematologic and biochemical indices within the ranges shown below at the screening visit
Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):
Group 3 - patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit.
Hemoglobin level at least 6.5 g/dL at Screening visit
Any prostate related investigational therapy within 6 months of Visit 1
Cryoablation should be performed within 14 days of screening visit
Prior radiation therapy of the index tumor <3 weeks prior to the screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Are postmenopausal for at least 1 year before the Screening visit , or
Exposure to other investigational products within 28 days prior to Screening Visit
Uncontrolled angina within 6 months before the Day 1 visit.
Subject has used any of the following within 28 days before the Day 1 visit:
Use of an investigational agent within 4 weeks before the screening visit;
Prior systemic treatment with an azole drug within four weeks of screening visit
Thromboembolism within 6 months of screening visit
Major surgery or radiation therapy within 30 days of screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Phase 1b subject has a positive drug or alcohol urine test at screening visit.
Are postmenopausal for at least 1 year before the screening visit, OR
Treatment with a systemic investigational agent within 28 days before the screening visit.
Were postmenopausal for at least 24 months before the screening visit, OR
The patient has pathologically documented AML and is in CR1 at the time of the screening visit
The patient achieved CR1 within 10 weeks of the screening visit; the patient may have received post-remission consolidation therapy (except for transplant) prior to the screening visit
The patient has not received an investigational chemotherapy within the last 28 days prior to the screening visit and has never received investigational immunotherapy. In addition, the patient must not receive treatment for AML (including treatment with IL-2 or IFN?) in the interval of time between the screening visit and initiation of pre-infusion preparative therapy
Subject has positive test result at the screening visit for one or more of the following:
Ability to adhere to dose and visit schedules.
Progression should have occurred within the immediate prior 2 months of the time of screening visit, with no intervening anti-cancer therapy
The presence of TAM as per below diagnostic criteria at baseline (or screening if baseline visit is skipped). All the criteria have to be met for the patients included in the study:
Any active, severe local or systemic infection at the screening visit
All subjects must be >/= 18 years at the first screening examination / visit
Active bleeding within 4 weeks prior to screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Are postmenopausal for at least 1 year before the screening visit, OR
Subjects taking immunosuppressive medications at the screening visit
Received AT treatment within the last 3 months prior to Screening visit.
Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
Are post-menopausal for at least 1 year before the screening visit, OR
Are postmenopausal for at least 1 year before the screening visit, OR
Any active, severe local or systemic infection at the screening visit
Undergone a therapeutic surgical procedure within 30 days from the screening visit.
Uncontrolled angina within 3 months of Screening visit;
History of GI bleeding within 6 months of Screening visit
All subjects must be ? 18 years at the first screening examination / visit
Other investigational therapy received within 8 weeks prior to screening visit
Are postmenopausal for at least 1 year before the screening visit, or
Have a documented visit with an oncologist during the previous 6-months
Participated in an investigational study for radiation dermatitis within 3 months of the screening visit
Severe illness at the time of the clinic visit
Subjects with a platelet count of at least 75 x 10^9/L at the screening visit
Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
Screening visit 2 must occur within 8 weeks prior to administration of the first dose of Polyphenon E
Positive urine drug test at screening visit
History of 3 or more biopsy confirmed BCCs in the preceding 2 years, calculated from 2 years prior to the screening visit; the number of BCCs found at the screening visit will not be included in the number of BCCs that qualify the subject for the study; if the subject after signing the consent form is found to not have had 3 BCCs prior to the screening visit then they will be a screen failure and will not enter the study
Subjects taking immunosuppressive medications at the screening visit (day 0)
Year 3 visit can not exceed 3 years and 6 months from the baseline visit
Subjects agree to be contacted 4-6 weeks after each study visit
Known pregnancy at study Visit 1.
Presenting for colposcopy at study Visit 1.
Total bilirubin within the normal range at the screening visit
Creatinine < (1.5 mg/dL) at the screening visit
Albumin > 30 g/L (3.0 g/dL) at the screening visit
Any Parkland outpatient visit during study period
Patients must have been seen for a visit for cancer surveillance between 2009 and 2013
Are postmenopausal for at least 1 year before the Screening visit, or