Health Condition 1: null- Solid tumors or Hematologic malignancies
Conditions
Interventions
Intervention1: P1446A-05: A minimum of 3 subjects per cohort will be dosed in a schedule of days 1-14 q 21-day cycle following which a safety assessment will be performed. The dose for the first cohor
or = 1 subject in a cohort experience first cycle DLT. Dose escalation will continue till maximum tolerated dose is achieved or unacceptable toxicity develop.
Control Intervention1: NIL: NIL
Sponsors
Piramal Life Sciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have histologically and/ or cytologically confirmed solid malignant tumor or hematologic malignancy that is refractory to currently available treatment or for which no standard treatment exists 2. Subjects of either sex and > or = 18 years of age 3. ECOG (Eastern Cooperative Oncology Group) performance status < or = 2 4. Subjects with life expectancy of at least 4 months 5. Hemoglobin > or = 8 g/dl 6. Absolute neutrophil count > or =1000/mm3 7. Platelet count > or = 50,000/ mm3 8. Total bilirubin < or = 1.5 X institutional upper limit of normal (ULN) 9. AST/ALT < or = 3 X institutional upper limit of normal (ULN) 10. Creatinine < or =1.5 X institutional upper limit of normal (ULN) 11. Ability to understand and willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: Subjects who have received radiotherapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks prior to day 1 of study drug administration (6 weeks for nitrosoureas or mitomycin C) or have not recovered completely from adverse effects of any prior radiotherapy, chemotherapy or biologic/targeted agents 2. Subjects who have received autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration 3. Subjects with known brain metastases at the time of screening 4. Subjects who had received any other investigational drug within 1 month or within five half-lives of the other investigational agent, whichever is longer prior to day 1 of study drug administration or who have not completely recovered from adverse effects of the investigational agent received prior to this period. 5. History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05. 6. Subjects on immunosuppressive therapy. 7. Clinically significant cardiac condition(s). The examples include but are not limited to past history or present: cardiac arrhythmia, myocardial infarction, Clinical Protocol No.P1446A-05/19/08 Confidential (Final version 5 dated 10 August 2010) Piramal Life Sciences Limited Page 20 of 65 cardiac failure, congenital cardiac disease, valvular heart disease, cardiomyopathy, myocarditis and pericardial diseases. 8. Subjects who require treatment with warfarin (coumadin) during the study. 9. Other medical co-morbidities that might be aggravated by protocol treatment including but not limited to serious infections, uncontrolled psychotic disorders and subjects who require supplemental oxygen. 10. Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B. 11. History of any other prior malignancy except for curatively treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been diseasefree for at least 3 years. 12. Women who are pregnant or lactating. 13. Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to study entry (after signing the informed consent document), during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised. 14. Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of P1446A-05 in subjects with advanced refractory malignanciesTimepoint: End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate safety and tolerability of P1446A-05 in the study population 2. To determine pharmacokinetics (PK) of P1446A-05 in the study population 3. To evaluate efficacy of P1446A-05 in the study population 4. To perform exploratory analysis of biomarkers associated with use of P1446A-05 in the study populationTimepoint: End of the study | — |
Countries
India
Contacts
Public ContactDr.Himanshu Parikh
Vice President - Clinical Research (R& D)
Outcome results
None listed