Study of PM060184 in Patients With Advanced Solid Tumors

NCT01299636 | Completed Phase 1

• 1 other identifier: PM60184-A-002-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

PM060184; Phase I; Pharma Mar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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

  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.

Study Arms (1)

PM060184

EXPERIMENTAL

Drug: PM060184

Interventions

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.

PM060184

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (1)

START- South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

plocabulin

Study Officials

• Kyriakos Papadopoulos, MD

  START- South Texas Accelerated Research Therapeutics, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 18, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

US (1)