Study of PM060184 in Patients With Advanced Solid Tumors

This study is currently recruiting participants.
Verified November 2013 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT01299636
First received: February 9, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: PM060184
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • MTD (maximum tolerated dose) and RD (recommended dose) of PM060184. [ Time Frame: From treatment onset to end of treatment ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PM060184 Drug: PM060184
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Voluntary signed and dated written informed consent.
  2. Patients with advanced solid tumors refractory to Standard therapy.
  3. Age >/= 18 years.
  4. Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia.
  5. Normal laboratory values within seven days prior to treatment administration.
  6. 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

  1. Pregnant or lactating women.
  2. Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy
  3. Prior treatment with any investigational product less than 30 days prior to the first.
  4. Central Nervous System metastases
  5. 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.
  6. Limitation of the patient's ability to comply with the treatment.
  7. Known hypersensitivity to any of the components of the drug product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299636

Contacts
Contact: Cinthya Coronado, M.D. + 34 91 846 61 35 ccoronado@pharmamar.com

Locations
United States, Texas
START- South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Kyriakos Papadopoulos, MD    210-593-5266    kyri.papadopoulos@start.stoh.com   
Principal Investigator: Kyriakos Papadopoulos, MD         
Sponsors and Collaborators
PharmaMar
Investigators
Principal Investigator: Kyriakos Papadopoulos, MD START- South Texas Accelerated Research Therapeutics, LLC
  More Information

No publications provided

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT01299636     History of Changes
Other Study ID Numbers: PM60184-A-002-10
Study First Received: February 9, 2011
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by PharmaMar:
PM060184
Phase I
Pharma Mar

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014