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

This study has been completed.

Sponsor:

Collaborator:

PPD

Information provided by:

Threshold Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00102752

First received: February 1, 2005

Last updated: April 28, 2009

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 1, 2005
Last Updated Date	April 28, 2009
Start Date ^ICMJE	December 2004
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Overall objective response rate
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00102752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Overall survival 6- and 12- month survival Progression-free survival Duration of objective response Serum CA-19-9
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer
Official Title ^ICMJE	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
Brief Summary	The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.
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 ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Neoplasms Pancreatic Neoplasms
Intervention ^ICMJE	Drug: Glufosfamide Drug: Gemcitabine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	47
Completion Date	July 2007
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Brazil

Administrative Information
NCT Number ^ICMJE	NCT00102752
Other Study ID Numbers ^ICMJE	TH-CR-301
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Threshold Pharmaceuticals
Collaborators ^ICMJE	PPD
Investigators ^ICMJE	Not Provided
Information Provided By	Threshold Pharmaceuticals
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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