Status:
COMPLETED
A Multicenter Phase I Clinical Study of a New Compound P1446A-05 in Patients With Advanced Refractory Malignancies
Lead Sponsor:
Piramal Enterprises Limited
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I study of a novel compound P1446A-05. Aim of this study is to identify the the recommended phase II dose of the drug and to determine the nature of adverse effects associated with the...
Eligibility Criteria
Inclusion
- Histologically and/ or cytologically confirmed solid malignant tumor or Malignant Lymphoma (excluding CNS Lymphoma and multiple myeloma) that is refractory to currently available treatment or for which no standard treatment exists
- Measurable disease
- Must have completed any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy or surgery at least 4 weeks (at least 6 weeks for nitrosureas and mitomycin C; 3 months for monoclonal antibodies, radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before study entry and subjects must have recovered (to ≤grade 1) from the toxic effects from any prior therapy.
- Must not have had more than 40% of their bone marrow radiated and must have either measurable disease outside the field or progression post radiation therapy.
- Age ≥ 18 years
- ECOG performance status ≤ 2
- Life expectancy of at least 12 weeks
- Normal organ and marrow function as defined below:
- Hemoglobin \>/= 90 g/L Leukocytes \>/=3 x 109/L Absolute Neutrophil Count (ANC) \>/=1.5 x 109/L Platelets \>/=100 x 109/L Total bilirubin \</= 1.5 X institutional Upper Limit of Normal (ULN) AST(SGOT) \</=2.5 X institutional ULN ALT(SGPT) \</=2.5 X institutional ULN Creatinine \</=1.5 X institutional ULN
- \- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration
- Known brain metastases at the time of screening
- Any other investigational drug within 1 month prior to day 1 of study drug administration or not recovered (to ≤grade 1) from adverse effects of the investigational agent received prior to this period.
- History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.
- On immunosuppressive therapy.
- History of unstable angina or myocardial infarction or stroke within 6 months prior to Day 1 of study drug administration.
- Uncontrolled inter-current illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.
- Pregnant or lactating women
- 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 (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a 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 drug, unless they are surgically sterilised.
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00772876
Start Date
December 1 2008
End Date
May 1 2012
Last Update
November 22 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T4N4N2
2
Cross Cancer Institute (CCI),
Edmonton, Alberta, Canada, T6G 1Z2
3
British Columbia Cancer Agency (BCCA),
Vancouver, British Columbia, Canada, BC V5Z 4E6
4
London Health Sciences Centre (LHSC)
London, Ontario, Canada, ON N6A 4L6