Study of PM060184 in Patients With Advanced Solid Tumors

NCT ID: NCT01299636

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

PM060184

Group Type: EXPERIMENTAL

PM060184

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyriakos Papadopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

START- South Texas Accelerated Research Therapeutics, LLC

Locations

START- South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PM60184-A-002-10

Identifier Type: -

Identifier Source: org_study_id