Skip to main content
OpenTrials
Completed

NCT Number: NCT00600964

A Phase I/II Study of GX15-070MS in Untreated CLL

This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Hospital, Toronto, Ontario, Canada

Loading trial locations.

About this study

Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed B-CLL
  • Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
  • Age ≥18 years
  • ECOG Performance Status ≤1
  • Life expectancy of >8 weeks

Exclusion criteria

  • Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
  • Patients with history of seizure disorders
  • Pregnant women and women who are breast feeding
  • HIV-positive patients receiving combination anti-retroviral therapy

Treatment and study plan

GX15-070MS

Drug

A 60-minute or 3-hour IV infusion every 2-3 weeks.

Other names: Obatoclax

Primary outcomes

  1. Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks

    Time frame: 14 days

Secondary outcomes

  1. Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Gemin X

Industry

Registry information

Official study title

A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 25, 2008
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.