NCT00493571

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of gimatecan that can be given to treat myelodysplastic syndrome (MDS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

6.8 years

First QC Date

June 27, 2007

Last Update Submit

May 11, 2015

Conditions

Myelodysplastic SyndromesMDS

Keywords

Myelodysplastic SyndromesMDSGimatecanLeukemia

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Gimatecan

    For purposes of estimating the MTD, 5 dose levels of Gimatecan initially considered. These dose levels are 3 mg, 5 mg, 7.5 mg, 8.75 mg, and 10 mg orally per cycle. Dose escalation based on toxicities observed through the first cycle.

    Evaulate with each 28 Day Cycle

Secondary Outcomes (1)

  • Efficacy in terms of complete remission , complete remission w/ incomplete platelet or neutrophil recovery (CRp and CRn, respectively), partial remission , and hematologic improvement.

    Up to 12 Months on Study

Study Arms (1)

Gimatecan

EXPERIMENTAL

Gimatecan Starting dose: 0.6 mg capsules administered orally once daily.

Drug: Gimatecan

Interventions

GimatecanDRUG

Starting dose: 0.6 mg capsules administered orally once daily.

Gimatecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with MDS with \>/= 5% blasts or IPSS risk group intermediate (1 or 2) or high (i.e., IPSS score 0.5 or higher).
  • Patients must have failed prior therapy with either chemotherapy (e.g., ara-C-based chemotherapy, etc) or biologic agents (e.g., hypomethylating agents, arsenic, thalidomide, CC5013, farnesyl transferase inhibitors, ATG, cyclosporine, etc).
  • Age \>/= 18 years. Because no dosing or adverse event data are currently available on the use of Gimatecan in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Patients must have normal organ function as defined below: 1) Total bilirubin: \</= 1.5 x institutional upper limit of normal; 2) ALT(SGPT): \</= 2.5 x institutional upper limit of normal; 3) Creatinine: \</= 1.5 x institutional upper limit of normal.
  • The effects of Gimatecan on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential (ie, not post-menopausal for at least 12 months and not surgically sterile) and men must agree to use double-barrier contraception prior to study entry, for the duration of study participation, and for 3 months following discontinuation of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Patients who have received only supportive care (transfusions and/or hematopoietic growth factors) for MDS.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives of the agent in question (6 weeks for nitrosoureas or mitomycin C), whichever is greater, prior to entering the study or those who have not recovered to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier. The use of hydroxyurea is allowed up to 48 hours prior to the start of therapy with Gimatecan.
  • Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia requiring and not responding to medical intervention, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia

Interventions

ST 1481

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Jorge E. Cortes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

August 1, 2007

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

US(1)