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Status:

COMPLETED

A Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies

Lead Sponsor:

Piramal Enterprises Limited

Conditions:

Solid Tumor

Hematologic Malignancy

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included...

Detailed Description

This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • Subjects of either sex and more than or equal to 18 years of age
  • ECOG (Eastern Cooperative Oncology Group) performance status less than or equal to 2
  • Subjects with life expectancy of at least 4 months
  • Hemoglobin greater than or equal to 8 g/dl
  • Absolute neutrophil count greater than or equal to 1000/mm3
  • Platelet count greater than or equal to 50,000/ mm3
  • Total bilirubin less than or equal to 1.5 X institutional upper limit of normal (ULN)
  • AST/ALT less than or equal to 3 X institutional upper limit of normal (ULN)
  • Creatinine less than or equal to 1.5 X institutional upper limit of normal (ULN)
  • Ability to understand and willingness to sign a written informed consent document.
  • 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
  • Subjects who have received autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration
  • Subjects with known brain metastases at the time of screening
  • 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.
  • History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.
  • Subjects on immunosuppressive therapy.
  • History of unstable angina or myocardial infarction or stroke within previous 6 months.
  • Subjects with 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.
  • Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.
  • 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.
  • Women who are pregnant or lactating.
  • 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.
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    December 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2011

    Estimated Enrollment :

    29 Patients enrolled

    Trial Details

    Trial ID

    NCT00840190

    Start Date

    December 1 2008

    End Date

    September 1 2011

    Last Update

    November 21 2012

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Tata Memorial Centre

    Mumbai, Maharashtra, India, 400012

    2

    Ruby Hall Clinic

    Pune, Maharashtra, India, 411 001

    3

    Jehangir Hospital

    Pune, Maharashtra, India, 411001

    4

    SEAROC Cancer Centre,

    Jaipur, Rajasthan, India, 302013