A Phase I Study of PM02734 in Subjects With Advanced Malignant Solid Tumors

NCT00404521 | Terminated Phase 1

• 1 other identifier: PM2734-A-001-05
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

Tumor; PM02734; PharmaMar

Outcome Measures

Primary Outcomes (1)

• To determine the safety, tolerability, dose limiting toxicities (DLT) and recommended dose (RD) of PM02734

  Along the study

Secondary Outcomes (1)

• To determine preliminary pharmacokinetics, to explore relationships between pharmacokinetics/pharmacodynamics correlation and to evaluate preliminary antitumor activity of PM02734

  Along the study

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: PM02734

Interventions

PM02734 DRUG

Administered every 3 weeks, intravenously, over 30 minutes

Arm 1

Eligibility Criteria

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

You may qualify if:

• 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).
• Alanine aminotransferase (ALT): ≤ 2.5 x ULN (\<5 x ULN in case of extensive liver metastases).
• Total bilirubin:1.5 ≤ ULN, unless due to Gilbert's syndrome.
• Creatinine: ≤ ULN, or measured creatinine clearance: ≥ 60 mL/min without significant proteinuria (\>250 mg/m2 /day)
• Albumin ≥ 2.5 g/dL.
• Partial thromboplastin time ≤ 1.1 x ULN

You may not qualify if:

• Prior therapy with PM02734.
• 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:
• History of significant neurological or psychiatric disorders.
• Active infection.
• Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
• Significant non-neoplastic renal disease.
• Immunocompromised subjects, including subjects known to be infected by human immunodeficiency virus (HIV).
• Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder) (i.e. requiring relevant changes in medication within the last month or hospital admission within the last 3 months).
• Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
• Limitation of the subject's ability to comply with the treatment or to follow-up at a participating protocol. Subjects registered on this trial must be treated and followed at a participating center.
• Treatment with ongoing anti-coagulation.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (1)

Cancer Research Center. University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

elisidepsin

Study Officials

• Mark Ratain, MD

  Cancer Research Centerr, University of Chicago Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: August 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

US (1)