Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia

NCT00047502 | Completed Phase 1 DMC

• 1 other identifier: ID02-221
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in combination with Gleevec in the treatment of CML.

Conditions

Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity (DLT)

  Dose-Limiting Toxicity (DLT) defined as grade 3 or 4 non-hematologic toxicity (NCI common criteria, version 2.0). Grade 3 or 4 nausea and vomiting considered DLT only if uncontrolled by antiemetics. Grade 3 or 4 diarrhea considered DLT only if uncontrolled for 48 hours despite adequate antidiarrheal therapy.

  3 months

Study Arms (1)

Gleevec + SCH 66336

EXPERIMENTAL

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.

Drug: Lonafarnib (SCH66336); Drug: Imatinib Mesylate (Gleevec)

Interventions

Lonafarnib (SCH66336) DRUG

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.

Also known as: SCH66336, Sarasar

Gleevec + SCH 66336

Imatinib Mesylate (Gleevec) DRUG

Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day. Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day.

Also known as: Gleevec, Imatinib, ST1571, NSC-716051

Gleevec + SCH 66336

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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• Patients with QTc \> 500 msec.
• Patients with severe heart disease (cardiac class III and IV) will be excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

lonafarnib; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Jorge E. Cortes, MD

  UT MD 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: October 8, 2002
• First Posted: October 9, 2002
• Study Start: November 1, 2002
• Primary Completion: April 10, 2006
• Study Completion: April 10, 2006
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (1)