A Phase I Single-institution, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM02734 Administered Every 3 Weeks, Intravenously, Over 30 Minutes, to Subjects With Advanced Malignant Solid Tumors.
Overview
- Phase
- Phase 1
- Intervention
- PM02734
- Conditions
- Solid Tumors
- Sponsor
- PharmaMar
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- To determine the safety, tolerability, dose limiting toxicities (DLT) and recommended dose (RD) of PM02734
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors.
Detailed Description
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors. Secondary objectives are to determine preliminary Pharmacokinetics of PM02734, to explore the relationships between pharmacokinetics and pharmacodynamics. To evaluate the preliminary pharmacokinetics/pharmacodynamics correlation and to evaluate the preliminary antitumor activity of PM02734. The trial will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntary written informed consent of the subject obtained before any study-specific procedure.
- •Histologically or cytologically confirmed malignant solid tumor.
- •Subjects with malignancies for which no standard therapy would reasonably be expected to result in cure or palliation.
- •Age ≥ 18 years.
- •Subject with measurable or non-measurable disease using the RECIST criteria (only subjects with measurable disease are allowed to enter the expanded cohort).
- •Recovery from any drug-related adverse event derived from previous treatment, excluding alopecia and NCI-CTCAE grade 1 symptomatic peripheral neuropathy.
- •Laboratory values within 7 days prior to first infusion:
- •Platelet count ≥ 100 x109/L , hemoglobin \> 9 g/dL and absolute neutrophil count (ANC) ≥ 1.5 x109/L.
- •Alkaline phosphatase ≤ 2.5 x the upper limit of normality (ULN) (\< 5 x ULN in case of extensive bone metastases).
- •Aspartate aminotransferase (AST): ≤ 2.5 x ULN (\<5 x ULN in case of extensive liver metastases).
Exclusion Criteria
- •Prior therapy with PM
- •Pregnant or lactating women.
- •Less than 4 weeks from radiation therapy (8 weeks in case of extensive prior radiotherapy) or last dose of hormonal therapy, biological therapy or chemotherapy (6 weeks in case of nitrosourea, mitomycin C, or high-dose chemotherapy).
- •Evidence of progressive CNS metastases or any symptomatic brain or leptomeningeal metastases.
- •Evidence of extensive liver metastases ( more than 5 hepatic nodules and some of them greater than 5 cm in diameter)
- •Other relevant diseases or adverse clinical conditions:
- •Increased cardiac risk: congestive heart failure or unstable angor pectoris or arrhythmia requiring treatment or uncontrolled arterial hypertension or myocardial infarction within 12 months before inclusion in the study.
- •History of significant neurological or psychiatric disorders.
- •Active infection.
- •Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
Arms & Interventions
Arm 1
Intervention: PM02734
Outcomes
Primary Outcomes
To determine the safety, tolerability, dose limiting toxicities (DLT) and recommended dose (RD) of PM02734
Time Frame: Along the study
Secondary Outcomes
- To determine preliminary pharmacokinetics, to explore relationships between pharmacokinetics/pharmacodynamics correlation and to evaluate preliminary antitumor activity of PM02734(Along the study)