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Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.

Outcome Description:

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.

Outcome Time Frame:

From treatment onset to end of treatment

Safety Issue:

Yes

Principal Investigator

Kyriakos Papadopoulos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

START- South Texas Accelerated Research Therapeutics, LLC

Authority:

United States: Food and Drug Administration

Study ID:

PM60184-A-002-10

NCT ID:

NCT01299636

Start Date:

January 2011

Completion Date:

August 2013

Related Keywords:

  • Solid Tumors
  • PM060184
  • Phase I
  • Pharma Mar
  • Neoplasms

Name

Location

START- South Texas Accelerated Research Therapeutics, LLCSan Antonio, Texas  78229