A Phase 1 Study for patients with advanced solid tumors.
- Conditions
- Health Condition 1: null- Patients with Advance solid Tumors
- Registration Number
- CTRI/2011/12/002225
- Lead Sponsor
- Orchid Research Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
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.
Serum creatinine less than or equal 1.5 ULN or calculated creatinine clearance greater than or equal 60 mL per min.
Alanine aminotransferase ALT and aspartate aminotransferase AST
less than or equal 2.5 ULN if no liver involvement, or less than or equal 5 ULN with liver involvement.
6 The subject is able to swallow and tolerate oral medications such as capsules.
7 The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
8 Sexually active subjects men and women must agree to use medicallyaccepted barrier methods of contraception eg, male condom, female
condom, or diaphragm with spermicidal gel during the course of the study and for 3 months after the last dose of study drugs, even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control.
9 Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include any woman who has
experienced menarche and who has not undergone successful surgical sterilization hysterectomy, bilateral tubal ligation, or bilateral oophorectomy or is not postmenopausal. Post menopause is defined as
Amenorrhea greater than or equal 12 consecutive months without another cause or
For women with irregular menstrual periods and on hormone replacement therapy, a documented serum follicle stimulating hormone FSH level 35 mIU per mL.
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.
10 The subject tests positive for the human immunodeficiency virus HIV, Hepatitis B virus (HBV) or Hepatitis C virus HCV at screening.
11 The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation.
12 The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method