Status:
COMPLETED
Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks
Lead Sponsor:
PharmaMar
Conditions:
Major Advanced Solid Tumors Other Than Colorectal
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.
Detailed Description
Phase I Study of PM01183 in Non-Colorectal (non-CRC) Cancer Patients to determine the recommended dose (RD) of PM01183, to characterize the safety profile, compliance and feasibility of the schedule, ...
Eligibility Criteria
Inclusion
- Voluntarily signed and dated written informed consent
- Age ≥ 18 years.
- Non or minimally daily activities-interfering disease related symptoms.
- Life expectancy ≥ 3 months.
- Patients with solid tumor other than CRC.
- Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ≤ 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).
- Normal cardiac function cardiac function by appropriate image testing.
- Women of childbearing potential must have a negative serum pregnancy test before study entry.
Exclusion
- Primary colorectal cancer diagnosis
- Prior treatment with PM01183.
- Concomitant diseases/conditions:
- a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol.
- Symptomatic and progressive or corticosteroid-requiring documented brain metastases
- Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
- History of extensive prior pelvic irradiation.
- History of previous bone marrow and/or stem cell transplantation.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01405391
Start Date
November 1 2011
End Date
January 1 2016
Last Update
January 15 2016
Active Locations (2)
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1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
2
Cancer Research Center. University of Chicago Hospitals
Chicago, Illinois, United States, 60637