Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed neurological condition placing subject at the increased risk of seizures.
Patients with a known history of seizures must have well-controlled seizures and may not be receiving enzyme-inducing anti-convulsants
Seizures within the past 12 months before enrollment
History of seizures
More than 2 seizures over the last 4 weeks prior to study entry
Patients with intractable seizures
Central Nervous System (CNS) Function defined as subjects with a known history of seizures must have well-controlled seizures and may not be receiving enzyme-inducing anti-convulsants, CNS toxicity <= Grade 2.
New onset seizures (within 3 months before planned randomization) or poorly controlled seizures
Patients with uncontrolled seizures defined as seizures that require regular use of rescue medications or in the opinion of the investigator require increasing doses of anti-epileptic medications or would compromise the ability to tolerate study therapy or interfere with protocol therapy or procedures; patients with seizures that are well controlled are eligible and may be on antiepileptic medications if on a stable dose
EXCLUSION CRITERIA FOR STRATUM C: Patients with uncontrolled seizures defined as seizures that require regular use of rescue medications or in the opinion of the investigator require increasing doses of antiepileptic medications or would compromise the ability to tolerate study therapy or interfere with protocol therapy or procedures; patients with seizures that are well controlled are eligible and may be on antiepileptic medications if on a stable dose
Patients with a confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to signing informed consent are ineligible
History of uncontrolled seizures within 6 months of randomization
History of seizures
No history of seizures, encephalitis, or multiple sclerosis
History or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication;
History of seizures
History of seizures
History of seizures in the past 3 years
New onset seizures (within 3 months prior to screening) or poorly controlled seizures
History of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
History of seizures
Subjects with a history of seizures
History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months
Patients with a history of seizures with in the past 3 months
History of seizures, movement disorders or cerebrovascular accident within the past 1 year prior to cycle 1 day 1
Prior seizures while on enzalutamide therapy
Patients who receive treatment with antiepileptic medications must have a two week history of stable dose of antiepileptic without seizures prior to dosing
Have experienced >2 seizures within 4 weeks prior to study entry.
History of seizures
History of significant bleeding disorder or uncontrolled seizures
History of significant neurologic or psychiatric disorders including dementia or seizures
History of seizures or extrapyramidal symptoms
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Patients with seizures due to CNS metastases must be controlled with stable anti-epileptic treatment for > 14 days
Patients with stable seizures (e.g., no seizures for >= 14 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible
History of uncontrolled seizures; (Note: patients are eligible for the study if the seizures are well controlled with standard medications)
Subjects who have experienced a seizure or seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic drugs for seizures (use of anti-epileptic drugs to control pain is allowed in subjects not suffering from seizures unless drug is excluded due to Cytochrome P450 3A4 induction - phenytoin, carbamazepine, Phenobarbital.
TUMOR BIOPSY SEQUENCING: Patients with history of central nervous system (CNS) metastases who have received treatment and who either have not had seizures or have been on stable doses of anti-seizure medicine and had no seizures for 4 weeks will be eligible; enzyme-inducing anticonvulsants are contraindicated
TREATMENT: Patients with a history of seizures are not eligible to receive veliparib, but patients with a history of CNS metastases who have received treatment and who either have not had seizures or have been on stable doses of anti-seizure medicine and had no seizures for >= 4 weeks will be eligible for other study agents; enzyme inducing anticonvulsants are contraindicated
TREATMENT: Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial; patients who have a history of seizures are not eligible to receive veliparib, but patients who have either not had seizures or who have been on stable doses of anti-seizure medicine and had no seizures for 4 weeks will be eligible for other study agents; enzyme-inducing anticonvulsants are contraindicated
New onset seizures (within 3 months prior to the first dose of rigosertib) or poorly controlled seizures.
Any history of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months
History of seizures
No brain metastasis, history of seizures, encephalitis, or multiple sclerosis
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures or history of seizures, and/or any CNS metastases are ineligible
For Cohort A: Has experienced a seizure or seizures within 6 months of study start or is currently being treated with cytochrome P450 enzyme (CYP) inducing anti-epileptic drugs for seizures
Patients must not have a history of seizures
Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
Subjects with a history of seizures must be on a stable dose of anti-epileptic drugs (AEDs) and without seizures for 14 days prior to enrollment in patients enrolled prior to Amendment 2. Subjects enrolled after Amendment 2 is approved with a history of seizures must be on a stable dose of anti-epileptic drugs (AEDs) for 7 days prior to enrollment.
New onset seizures (within 3 months prior to Screening) or poorly controlled seizures.
Presence of uncontrolled seizures =< 5 days prior first drug dose, defined as status epilepticus or multiple seizures not responding to appropriate therapy
Diabetics on a stable dose of insulin or antihyperglycemic regimen are allowed if they have had no prior seizures and no history of loss of consciousness due to hypoglycemia
History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
History of seizures, movement disorders or cerebrovascular accident within the past 5 years
History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
More than 2 seizures over the last 4 weeks prior to study entry
Brain metastases are allowed if well controlled and without seizures
Seizures or history of seizures
Patients with history of active seizures are not eligible
More than two seizures over the last 4 weeks prior to study entry
g. Untreated and uncontrolled epileptic seizures
History of seizures.
History of significant neurologic or psychiatric disorders, including dementia or seizures that would impede consent, treatment, or follow up
History of prior seizures
History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
Patients with a prior history of seizures within the past year unrelated to brain metastases
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
History of epilepsy or seizures in the past 20 years.
Patients with uncontrolled seizures or any neurological conditions resulting in increased risk for seizures are not eligible for study entry
No history of seizures
Recurring seizures resulting from the head injury
Any disorder that would predispose the participant to seizures
History of seizures
No history of epilepsy/seizures
History of seizures
History of seizures
Patients with tumor-induced seizures must be well controlled on a stable anti-epileptic treatment
No history of seizures related to the brain metastases or LMD.
History of any neurological disorders or seizures.
History of seizures
Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
History of active autoimmune disorders
History of or active autoimmune disorders
Patients must satisfy the criteria for a diagnosis of one of the severe neurological autoimmune disorders outlined
Active or prior documented autoimmune or inflammatory disorders.
Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:\r\n* The presence of laboratory evidence of autoimmune disease (e.g. positive antinuclear antibodies [ANA] titer) without symptoms.\r\n* Clinical evidence of vitiligo.\r\n* Hypothyroidism of any etiology on stable thyroid hormone replacement therapy.\r\n* Other forms of depigmenting illness.\r\n* Mild arthritis requiring nonsteroidal antiinflammatory drug (NSAID) medications.
Developed autoimmune disorders of Grade 4 while on prior immunotherapy. Subjects who developed autoimmune disorders, of Grade ? 3 may enroll if the disorder has resolved to Grade ?1 and the subject has been off systemic steroids at doses >10 mg/day, for the treatment of the autoimmune disorder, for at least 2 weeks.
Active or prior documented autoimmune or inflammatory disorders
Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
Uncontrolled autoimmune disorders. Patients with autoimmune disorders under control on medication may be included. Patients with pure red cell aplasia may be included if hemoglobin levels are relatively stable on transfusions or medication
History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders
Autoimmune disorders on current immunosuppressive therapy
Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement
Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement
Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement
Active/prior autoimmune of inflammatory disorders
Autoimmune disorders on current immunosuppressive therapy
History of autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement; active or inactive auto-immune disorders (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, etc.) requiring treatment\r\n* The following will not be exclusionary:\r\n** Vitiligo, thyroiditis or eczema requiring systemic steroids at a dose =< 7.5 mg/day of prednisone or equivalent; individual cases can be discussed with the principal investigator
Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement; participants must not have an active or inactive autoimmune disorders (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.); participants who are receiving therapy for an autoimmune or inflammatory disease requiring these therapies are also excluded
Autoimmune disorders and other diseases that compromise or impair the immune system.
No history of autoimmune disorders
Known clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control
Patients on immunosuppressive therapy or with immune system disorders, including autoimmune disease
Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.
Autoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders.
Active or prior documented autoimmune or inflammatory disorders within the past 3 years.
Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
Active or prior documented autoimmune or inflammatory disorders;
Active or prior documented autoimmune or inflammatory disorders;
Patients with existing autoimmune disorders (IL-2 and GM-CSF carry a theoretical clinical risk of exacerbating underlying autoimmune disorders)
History of active autoimmune disorders
Autoimmune disorders
Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
Active or prior documented autoimmune or inflammatory disorders
Diagnosis of autoimmune disorders
Clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control
Active or history of autoimmune disorders/conditions.
Known clinically significant autoimmune disorders requiring systemic immunosuppression for control
Developed autoimmune disorders of Grade 4 while on prior immunotherapy. Subjects who developed autoimmune disorders of Grade ? 3 may enroll if the disorder has resolved to Grade ?1 and the subject has been off systemic steroids at doses >10 mg/day for at least 2 weeks.
Active or prior documented autoimmune or inflammatory disorders
Patients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with Medical Monitor approval).
Have active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents in the past 2 years.
The subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Active autoimmune disease, or documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
The participant has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Presence of autoimmune disease that requires corticosteroids and/or immunosuppressive agents.
An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
Subjects with active autoimmune disease or a syndrome that requires systemic corticosteroids
An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
No history of autoimmune disease requiring systemic therapy (e.g. steroids or biologic agents)
Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, except \r\n* Patients with vitiligo or well controlled asthma/atopy\r\n* Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome
Active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents.
Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents
Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
History of interstitial lung disease, pneumonitis, autoimmune disease or syndrome that requires steroids or immunosuppressive agents.
The participant has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents
Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids.
Subjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications
Have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years.