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CompletedNCT00025454Updated Feb 8, 2010

R115777 in Treating Patients With Advanced Solid Tumors

A Phase 1 interventional study of tipifarnib in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by City of Hope Medical Center. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-08.

Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have advanced solid tumors.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors.
  • Assess the toxicity of this drug in these patients.
  • Determine, preliminarily, the efficacy of this drug in these patients.
  • Determine the potential predictors of response in patients treated with drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

Browse Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant tumors deemed to be incurable or refractory to therapy

    • Advanced, recurrent, or metastatic disease
  • Previously treated with at least 1 chemotherapy regimen
  • Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm3
  • Absolute granulocyte count at least 1,500/mm3
  • Platelet count at least 75,000/mm3

Hepatic:

  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN

Renal:

  • Creatinine clearance at least 60 mL/min OR
  • Creatinine no greater than 1.6 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present
  • No concurrent radiotherapy to measurable lesions

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered

Other:

  • At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole)
  • Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between H2 blocker/antacid intake and R115777 dosing
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • Drugtipifarnib
06

Study locations

4 sites
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90033-0804, United States
  • City of Hope Medical Group
    Pasadena, California 91105, United States
  • University of California Davis Cancer Center
    Sacramento, California 95817, United States
07

References and documents

Publications

  • Lara PN Jr, Law LY, Wright JJ, Frankel P, Twardowski P, Lenz HJ, Lau DH, Kawaguchi T, Gumerlock PH, Doroshow JH, Gandara DR. Intermittent dosing of the farnesyl transferase inhibitor tipifarnib (R115777) in advanced malignant solid tumors: a phase I California Cancer Consortium Trial. Anticancer Drugs. 2005 Mar;16(3):317-21. doi: 10.1097/00001813-200503000-00011. PubMed 15711184 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00025454
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Aug 2001
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Feb 8, 2010

Study contacts

Primo N. Lara, MD
study chair · University of California, Davis
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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