Clinical trial NCT01299636: Study of PM060184 in Patients With Advanced Solid Tumors
Official title: Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: PM060184
Phase I
Pharma Mar
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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.

Primary outcomes:
measure: MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
timeFrame: From treatment onset to end of treatment
Secondary outcomes:
measure: To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.
timeFrame: 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.
measure: Antitumor activity
timeFrame: 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.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: START- South Texas Accelerated Research Therapeutics, LLC
state: Texas
Study officials:
affiliation: START- South Texas Accelerated Research Therapeutics, LLC
name: Kyriakos Papadopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: