Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

April 28, 2009 updated by: Threshold Pharmaceuticals

A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma

The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.

Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

Study Type

Interventional

Enrollment

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • BH
      • Nova Lima, BH, Brazil, 34000-000
        • Hospital de Doenças Cardiovasculares - Biocor
    • RS
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Porto Alegre, RS, Brazil, 90880-480
        • Hospital Mae de Deus
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Fundação Pio XII - Hospital de Câncer de Barretos
      • São Paulo, SP, Brazil, 04023-900
        • Universidade Federal de São Paulo - Hospital São Paulo
      • São Paulo, SP, Brazil, 05651-901
        • Hospital Israelita Albert Einstein
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
  • Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
  • Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
  • Recovered from reversible toxicities of prior therapy
  • Karnofsky performance status ≥70
  • Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose
  • Ability to understand the purposes and risks of the study and provide written informed consent.

Exclusion Criteria:

  • Prior chemotherapy for metastatic/locally advanced pancreatic cancer
  • Prior administration of gemcitabine
  • Radiation therapy within 28 days prior to study start
  • Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 days prior to study start
  • Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
  • Active, clinically significant infection requiring antibiotics
  • Known HIV positive or active hepatitis B or C
  • History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
  • Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
  • Major surgery within 3 weeks of the start of study treatment, without complete recovery

  • Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)

    • Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain),
    • ANC <1500/μL,
    • Platelet count <100,000/μL,
    • Total bilirubin > 1.5 ×ULN,
    • AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases),
    • Serum creatinine > 2 mg/dL,
    • Creatinine clearance < 60 mL/min (calculated)
  • Females who are pregnant or breast-feeding
  • Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
  • Concomitant disease or condition that could interfere with the conduct of the study
  • Unwillingness or inability to comply with the study protocol for any other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall objective response rate

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
6- and 12- month survival
Duration of objective response
Serum CA-19-9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Threshold Pharmaceuticals

Collaborators

PPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 1, 2005

First Submitted That Met QC Criteria

February 1, 2005

First Posted (Estimate)

February 2, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2009

Last Update Submitted That Met QC Criteria

April 28, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH-CR-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Clinical Trials on Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe