A Multicentric Phase 1 Study of P7170 in Patients with Refractory Solid Tumors
- Conditions
- Health Condition 1: null- metastatic or unresectable Non-haematological malignancy
- Registration Number
- CTRI/2012/07/002787
- Lead Sponsor
- Piramal Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 60
1. Patients having histologically and/or cytologically confirmed non-haematological malignancy that is metastatic or unresectable and for which standard curative/palliative treatment does not exist or is no longer effective or is not tolerated by patient.
2. Patients of either sex, of all races and ethnic groups, and > 18 years of age.
3. ECOG (Eastern Cooperative Oncology Group) performance status < 2.
4. Patients with life expectancy of at least 4 months.
5. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
6. Patients must have adequate organ and marrow function as defined below:
a. Absolute neutrophil count > 1500/cmm
b. Platelets > 100,000/cmm
c. Total bilirubin within normal limits of the institution.
d. AST/ALT < 2.5 X institutional upper limit of normal (ULN)
e. Creatinine < 1.5 X institutional upper limit of normal (ULN)
7. Women of childbearing potential and men willing to agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised.
8. Ability to understand and the willingness to provide a written informed consent document.
1. Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy or surgery within 4 weeks (3 months for monoclonal antibodies, radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before study drug administration and have not recovered (to grade 1) from the toxic effects from any prior therapy.
2. Patients having received any other investigational agents within 4 weeks prior to the date of enrolment and have not recovered completely (to grade 1) from the side effects of the earlier investigational agent.
3. Patients with known brain metastases (except for patients who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for two months prior to first dose of study drug).
4. Patients with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
5. Patients with diabetes mellitus requiring insulin therapy at screening or patients with clinically significant diabetic complications, such as neuropathy, retinopathy, peripheral vascular disease or nephropathy.
6. Clinically significant medical condition of malabsorption, inflammatory bowel disease, or chronic diarrheal condition that might affect the absorption of the investigational agent.
7. Patients on chronic anticoagulation treatment.
8. Patients with inter-current illness including, but not limited to ongoing or clinically significant active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
9. Patients with a known history of allergic reaction to any other medication considered to be clinically significant by the investigator.
10. Women who are pregnant or nursing.
11. Patients with immune deficiency and at increased risk of lethal infections, for example, known h/o HIV, HBV or HCV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method