CTRI/2011/12/002225
Not yet recruiting
Phase 1
A Phase 1 Dose-Escalation Study of the Safety andPharmacokinetics of Daily OCID 4681-S-01 Administered Orally to Subjects with Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Orchid Research Laboratories Ltd
- Enrollment
- 36
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 The subject has a histologically confirmed solid tumor that is metastatic or unresectable and is no longer responding to therapies known to prolong survival or to other standard therapies, or has disease for which no standard
- •therapy exists.
- •2 The subject is greater than or equal to 18 years old.
- •3 The subject has an Eastern Cooperative Oncology Group ECOG performance status of 0 to 2 Appendix B
- •4 Subject has a life expectancy of greater than 3 months.
- •5 The subject has adequate organ and marrow function as follows
- •Absolute neutrophil count ANC greater than or equal 1500mm3\.
- •Platelets greater than or equal 100,000mm3\.
- •Hemoglobin greater than or equal 10 g per dL, with no transfusions within the last seven days.
- •Bilirubin less than or equal 1\.5 the upper limit of normal ULN.
Exclusion Criteria
- •1 The subject has received cytotoxic chemotherapy including investigational cytotoxic chemotherapy or biologic agents eg, cytokines or antibodies within 3 weeks, or nitrosoureas or
- •mitomycin C within 6 weeks before the first dose of study treatment.
- •2 The subject has received radiation therapy within 14 days of the first dose of study treatment. Palliative radiation to nonmarrow areas is allowed.
- •3 The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
- •4 The subject has not recovered from toxicity due to all prior therapies ie, return to pretherapy baseline or to Grade 0 or 1
- •5 The subject has received lifetime radiation to 25 percent of his or her bone marrow before the first dose of study treatment.
- •6 The subject has a primary brain tumor or brain metastases.
- •7 The subject has prothrombin time PT International Normalized Ratio INR or partial thromboplastin time PTT test results at screening that are 1\.3 times the laboratory ULN.
- •8 The subject has uncontrolled significant intercurrent illness including, but not limited to ongoing or active infection, history of congestive heart failure within 6 months, uncontrolled hypertension or unstable angina pectoris within 6 months, stroke within 3 months, myocardial infarction within 3 months, or cardiac arrhythmias.
- •9 The subject is pregnant or breastfeeding.
Outcomes
Primary Outcomes
Not specified
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