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Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients

Phase 1
18 Years
Open (Enrolling)
Major Advanced Solid Tumors Other Than Colorectal

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Trial Information

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients

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, to optimize and individualize PM01183 dosing in non-CRC
patients according to individual tolerance, to characterize the pharmacokinetics (PK) of the
schedule, to obtain preliminary information on the clinical antitumor activity and to
perform an exploratory pharmacogenomics (PGx) analysis.

Inclusion Criteria:

1. Voluntarily signed and dated written informed consent

2. Age ≥ 18 years.

3. Non or minimally daily activities-interfering disease related symptoms.

4. Life expectancy ≥ 3 months.

5. Patients with solid tumor other than CRC.

6. 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).

7. Normal cardiac function cardiac function by appropriate image testing.

8. Women of childbearing potential must have a negative serum pregnancy test before
study entry.

Exclusion Criteria:

1. Primary colorectal cancer diagnosis

2. Prior treatment with PM01183.

3. 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.

4. Symptomatic and progressive or corticosteroid-requiring documented brain metastases

5. 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.

6. History of extensive prior pelvic irradiation.

7. History of previous bone marrow and/or stem cell transplantation.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose (RD)

Outcome Description:

To determine the recommended dose (RD) of PM01183 administered as a 1-hour infusion intravenously (i.v.) on Days 1 and 8 every three weeks (q3wk) in non-colorectal cancer (non-CRC) patients.

Outcome Time Frame:

From treatment onset to end of treatment

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

November 2013

Related Keywords:

  • Major Advanced Solid Tumors Other Than Colorectal
  • Pharma Mar
  • PM01183
  • Non-Colorectal Cancer (non-CRC)
  • Dose finding phase I



University of Colorado Cancer Center Denver, Colorado  80262
Cancer Research Center. University of Chicago Hospitals Chicago, Illinois  60637