NCT00034684

Brief Summary

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_1 leukemia

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

Study Start

First participant enrolled

July 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

May 1, 2002

Last Update Submit

June 16, 2015

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myeloid, ChronicBlast CrisisLeukemia, Lymphocytic

Keywords

LeukemiaMyelodysplastic SyndromesLeukemia, MyeloidLeukemia, Lymphocytic

Interventions

Farnesyl Protein Transferase InhibitorDRUG

Eligibility Criteria

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

You may qualify if:

  • Pathologically documented chronic myelogenous leukemia in blast crisis, myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia.
  • Life expectancy of 12 weeks or greater.
  • ECOG Performance Status less than or equal to 2.
  • Meets protocol requirements for specified laboratory values.
  • No manifestations of a malabsorption syndrome.

You may not qualify if:

  • Patients who have received more than three chemotherapy regimens for more than three recurrences of the disease.
  • Poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled conditions.
  • Patients who have received investigational therapy of any type within 30 days prior to administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveBlast CrisisLeukemia, LymphoidLeukemia, Myeloid

Interventions

2-(2-oxo-2-((3,7,11-trimethyl-2,6,10-dodecatrienyl)oxy)aminoethyl)phosphonic acid, (2,2-dimethyl-1-oxopropoxy)methyl ester sodium

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2002

First Posted

May 2, 2002

Study Start

July 1, 2001

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

June 17, 2015

Record last verified: 2015-06