Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Geron Corporation

ClinicalTrials.gov Identifier:

NCT00310895

First received: April 4, 2006

Last updated: January 9, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 4, 2006
Last Updated Date	January 9, 2013
Start Date ^ICMJE	March 2006
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 8, 2009)	Safety, DLT, and MTD [ Time Frame: Measured during the first cycle of treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: April 4, 2006)	Safety measured during each dose administration Tolerability of each dose administration Dose-limiting toxicities evaluated at each dose administration Maximum tolerated dose
Change History	Complete list of historical versions of study NCT00310895 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 8, 2009)	PK profile and disease response [ Time Frame: Within the first 2 cycles of treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: April 4, 2006)	Pharmacokinetic profile of GRN163L measured for 2 cycles Preliminary antineoplastic activity
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
Official Title ^ICMJE	A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
Brief Summary	The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
Detailed Description	GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Solid Tumor Malignancies
Intervention ^ICMJE	Drug: Imetelstat Sodium (GRN163L) Dose increase by 25% if tolerated infused over 2 hours
Study Arm (s)	Experimental: Dose escalation Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle) Intervention: Drug: Imetelstat Sodium (GRN163L)
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	Active, not recruiting
Estimated Enrollment ^ICMJE	85
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 years of age or older Male or female Measurable or evaluable solid tumor malignancy Relapsed, refractory, locally advanced, or metastatic disease Disease refractory to or not amenable to standard therapy Karnofsky performance status 70-100% Life expectancy 3 months or greater Exclusion Criteria: Pregnant or lactating women Primary central nervous system(CNS) malignancy or active CNS metastases Hematologic malignancy Chemotherapy within 4 weeks prior to study Mitomycin C, nitrosoureas within 6 weeks prior to study High dose chemotherapy with stem cell support within 6 months prior to study Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study Systemic hormonal therapy within 4 weeks prior to study Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study Radiotherapy within 4 weeks prior to study Significant cardiovascular disease Serious/active infection Major surgical procedures within 2 weeks
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

Administrative Information
NCT Number ^ICMJE	NCT00310895
Other Study ID Numbers ^ICMJE	GRN163L CP05-101
Has Data Monitoring Committee	No
Responsible Party	Geron Corporation
Study Sponsor ^ICMJE	Geron Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Geron Corporation
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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