Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks
Completed · Phase 1
Conditions studied: Major Advanced Solid Tumors Other Than Colorectal
In brief
Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.
Key facts
- Study ID
- NCT01405391
- Run by
- PharmaMar
- People needed
- 42
- Starts
- 2011-11-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Cancer Research Center. University of Chicago Hospitals — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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