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Completed

NCT Number: NCT01299636

Study of PM060184 in Patients With Advanced Solid Tumors

The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

START- South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

About this study

This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Voluntary signed and dated written informed consent.
  • Patients with advanced solid tumors refractory to Standard therapy.
  • Age >/= 18 years.
  • Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia.
  • Normal laboratory values within seven days prior to treatment administration.
  • Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.

Exclusion criteria

  • Pregnant or lactating women.
  • Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy
  • Prior treatment with any investigational product less than 30 days prior to the first.
  • Central Nervous System metastases
  • Other relevant diseases or adverse clinical conditions:
  • Increased cardiac risk:
  • Presence of significant neurological or psychiatric disorders
  • Neuropathy
  • Active infection requiring treatment.
  • Liver disease (e.g., cirrhosis, hepatitis).
  • Immunocompromised patients.
  • Any other major illness.
  • Limitation of the patient's ability to comply with the treatment.
  • Known hypersensitivity to any of the components of the drug product.

Treatment and study plan

PM060184

Drug

PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days.

Primary outcomes

  1. MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.

    Time frame: From treatment onset to end of treatment

    To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.

Secondary outcomes

  1. To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.

    Time frame: Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle.

    The complete plasma concentration-time profiles of PM06184 will be analyzed by standard non-compartmental methods.The percent of PM060184 total dose excreted unchanged into the urine over the collection interval will be calculated from the urine samples.

  2. Antitumor activity

    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.

    Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study title

Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2011
Registry last updated
Nov 2, 2015

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.

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