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Completed

NCT Number: NCT01405391

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

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

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Key information

Conditions

Major Advanced Solid Tumors Other Than Colorectal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Cancer Center, Aurora, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

PM01183

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2011
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.