Study of PM060184 in Patients With Advanced Solid Tumors

Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to 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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: PM060184

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • START- South Texas Accelerated Research Therapeutics, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.	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.	From treatment onset to end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.	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.	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.
Antitumor activity	Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers	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.

Collaborators and Investigators

• Sponsor: PharmaMar
• Investigators: Principal Investigator: Kyriakos Papadopoulos, MD, START- South Texas Accelerated Research Therapeutics, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Phase I; Pharma Mar; PM060184
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PM60184-A-002-10