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Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405391
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : January 15, 2016
Information provided by (Responsible Party):

Brief Summary:
Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.

Condition or disease Intervention/treatment Phase
Major Advanced Solid Tumors Other Than Colorectal Drug: PM01183 Phase 1

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, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: A
Patients will receive PM01183 on Days 1 and 8 q3wk (three weeks = one treatment cycle) as an i.v. infusion, starting at 3.0 mg/day, flat dose (FD), over a minimum total volume of 100 ml dilution (on 5% glucose or 0.9% sodium chloride) via a central catheter or over a minimum total volume of 250 ml via a peripheral line, over one hour (at a fixed rate) and through a pump device.
Drug: PM01183
PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths, 1 mg and 4 mg vials. Before use, the 1 mg and 4 mg vials should be reconstituted with 2 ml and 8 ml of water for injection respectively, to give a solution containing 0.5 mg/ml PM01183. For administration to patients as an i.v. infusion, reconstituted vials are diluted with glucose 50 mg/ml (5%) solution for infusion or sodium chloride 9 mg/ml (0.9%) solution for infusion.

Primary Outcome Measures :
  1. Recommended dose (RD) [ Time Frame: From treatment onset to end of treatment ]
    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.

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): The dose-exposure relationships for Cmax and area under the curve (AUC) will be evaluated. [ Time Frame: During the infusions administered on Day 1 of Cycles 1 and 3, with a schedule of 13 samples. ]
    To characterize the pharmacokinetics (PK) of this schedule and explore factors that may affect individual variability in main PK parameters.

  2. Antitumor activity measured clinically and/or radiologically according to RECIST or by evaluation of tumor markers [ Time Frame: Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first. ]
    RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.

  3. Pharmacogenomics (PGx) analysis: Number of tumour patient samples with identified and validated putative molecular markers associated with the clinical outcome of non-CRC patients treated with PM01183. [ Time Frame: At the end of the study (24 months) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405391

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United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Illinois
Cancer Research Center. University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Sponsors and Collaborators

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Responsible Party: PharmaMar Identifier: NCT01405391    
Other Study ID Numbers: PM1183-A-005-11
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by PharmaMar:
Pharma Mar
Non-Colorectal Cancer (non-CRC)
Dose finding phase I