Clinical trial NCT01538537 (phase 1, status: completed)
Conditions: advanced cancer, solid tumors, cancer, neoplasms
ICD codes: K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: rigosertib sodium
SMILES: COC1=CC(OC)=C(\C=C\S(=O)(=O)CC2=CC=C(OC)C(NCC(O)=O)=C2)C(OC)=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have histologically confirmed malignancy that is metastatic or
             unresectable and for which standard curative or palliative measures do not exist or
             are no longer effective.

          -  At least 4 weeks since the last dose of other potentially myelosuppressive treatment
             (at least 6 weeks since last dose of nitrosoureas or mitomycin C) and recovery from
             manifestations of reversible drug toxicity (except alopecia, stable residual
             neuropathy, and residual hand and foot syndrome). Among patients with prior
             doxorubicin chemotherapy, only those with no more than 450 mg/m2 of the drug will be
             entered. It must be at least 4 weeks since prior chemotherapy or radiation therapy, 6
             weeks if the last regimen included nitrosoureas or mitomycin C.

          -  Patients with prior radiotherapy are eligible provided that a minimum of 4 weeks have
             passed and that the maximal area of hematopoietic active bone marrow treated was less
             than 25%.

          -  ECOG performance status < 2.

          -  Hgb > 10 gm/dl

          -  WBC > 4,000 per microliter

          -  Absolute neutrophil count > 1,500 per microliter

          -  Platelets >100,000 per microliter

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT)/ALT(SGPT) values within limits defined by Protocol

          -  Creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73
             m2 for patients with creatinine levels above institutional normal.

          -  Women of child-bearing potential and men must agree to use adequate contraception.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Inclusion Criteria - Dose Confirmation Phase Same inclusion criteria as in the Dose
        Escalation phase described above, except Patients must have an ECOG performance of 0 or 1.

        Exclusion Criteria:

          -  Patients who have had recent major surgery (within the past 14 days), chemotherapy or
             radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to
             entering the study or those who have not recovered from adverse events (except
             alopecia, stable residual neuropathy, and residual hand and foot syndrome) due to
             previously administered agents.

          -  Patients may not be receiving any other investigational agents or concurrent
             chemotherapy, radiotherapy, hormonal treatments, or immunotherapy while on study.

          -  Patients with known or clinical evidence of central nervous system metastasis, except
             brain metastases that have been previously removed or irradiated and currently have no
             clinical impact.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ON 01910.Na.

          -  The patient should have no major 3rd space fluid, ascites requiring active medical
             management including paracentesis, peripheral bilateral edema, or hyponatremia (serum
             sodium value less than 134 Meq/L).

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, bleeding, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements.

          -  Pregnant and nursing women are excluded from this study.

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study.