Health Condition 1: null- Patients with Advanced Cancer
Conditions
Interventions
Intervention1: oral ON 01910.Na: ON 01910.Na Administered Orally as Escalating Single and Multiple Doses Twice a Day up to 14 Days of a 21-Day Cycle
Comparator: No Comparator
Control Intervention1:
Sponsors
Onconova Therapeutics Inc
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years of age 2. Histologically confirmed solid tumor (leukemias and lymphomas excluded) 3. Malignancy that is incurable and for which standard (FDA approved or established standard clinical practice), curative, or palliative measures do not exist or are no longer effective. 4. ECOG performance status 2 (see Attachment I) 5. Life expectancy 6 months. 6. One or more measurable lesion(s) (?target lesion[s]?), that can be accurately measured in at least 1 dimension with longest diameter 20 mm using conventional techniques (computed tomography [CT] scan or magnetic resonance imaging [MRI]) or 10 mm with spiral CT scan ? Target lesion(s) must be outside of a previously irradiated area ? Bone metastasis alone may not be considered to be a target lesion 7. If female, has a negative screening for pregnancy. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry (hormonal or barrier method of birth control; abstinence) and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately 8. Ability to understand the nature of the study and any hazards of participating in it, to communicate satisfactorily with the investigator, and to participate in, and comply with, the requirements of the entire study. 9. Willing to adhere to the prohibitions and restrictions specified in this protocol 10. Patient (or his/her legally authorized representative) must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Recent major surgery (within the past 14 days) 2. Chemotherapy or dose of other potentially myelosuppressive treatment within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C) 3. Among patients with prior doxorubicin chemotherapy, only those with no more than a total cumulative dose of 450 mg/m2 of the drug. 4. Radiotherapy within 4 weeks prior to entering the study and maximal area of hematopoietic active bone marrow treated was greater than 25%. 5. Residual adverse events (except alopecia, stable residual neuropathy, and residual hand, foot syndrome and ascites requiring active medical management including paracentesis, peripheral bilateral edema, hyponaremia (serum value less than 134 Meq/L)) due to previously administered agents. 6. Receiving any other investigational agents or concurrent chemotherapy, radiotherapy, hormonal treatments, bone marrow transplantation, or immunotherapy while on study. 7. Previous bone marrow transplant. 8. Known brain metastases, except brain metastases that have been previously removed or irradiated and currently have no clinical impact. 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ON 01910.Na. 10. 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. 11. Hgb 9 gm/dL (must not require transfusional support but erythropoietin therapy is permitted) 12. WBC 4,000/?ÝL 13. Absolute neutrophil count 1,500/?ÝL 14. Platelets 100,000/?ÝL 15. Total bilirubin greater than 1.5 times institutional upper normal limit. 16. AST (SGOT) / ALT (SGPT) 2.5 x institutional upper normal limit. (If liver function abnormalities are due to metastatic disease, patients are eligible provided the transaminases are 5 times institutional upper normal limit. 17. Serum creatinine greater than normal institutional limits or estimated creatinine clearance 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 18. Patients with primary liver disease with these parameters will be ineligible. 19. Pregnant and nursing women. 20. HIV-1positive patients receiving combination anti-retroviral therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore and characterize pharmacokinetics following fasting oral administration of single and multiple doses of ON 01910.Na Timepoint: 21 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Manmohan Acharya
Outcome results
None listed