NCT00243035

Brief Summary

This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with bortezomib and to see how well they work in treating patients with relapsed multiple myeloma. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer cells.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

October 20, 2005

Last Update Submit

October 7, 2013

Conditions

Refractory Multiple MyelomaStage II Multiple MyelomaStage III Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose of tipifarnib as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 (phase I)

    Up to day 21

  • Response rate (complete response [CR] + partial response [PR]) determined using the Bladé Response criteria (phase II)

    Exact 95% confidence intervals constructed.

    Up to 6 weeks

  • Toxicities, graded according to the NCI CTCAE v3.0 (phase II)

    Up to 2 years

Secondary Outcomes (9)

  • Proportion of patients overcoming CAM-DR

    Prior to therapy

  • Proportion of patients overcoming CAM-DR

    Day 11 of course 1

  • Relationship of overcoming CAM-DR and clinical response

    Prior to therapy

  • Relationship of overcoming CAM-DR and clinical response

    Day 11 of course 1

  • Clinical resistance and levels of phosphorylated Akt

    Prior to therapy

  • +4 more secondary outcomes

Study Arms (1)

Treatment (bortezomib, tipifarnib)

EXPERIMENTAL

Phase I: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral tipifarnib twice daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tipifarnib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive bortezomib as in phase I and tipifarnib as in phase I at the MTD.

Drug: bortezomibDrug: tipifarnibOther: laboratory biomarker analysis

Interventions

bortezomibDRUG

Given IV

Treatment (bortezomib, tipifarnib)
tipifarnibDRUG

Given orally

Treatment (bortezomib, tipifarnib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bortezomib, tipifarnib)

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of multiple myeloma
  • Stage II or III disease
  • Relapsed disease after ≥ 2 prior therapies\*, confirmed by the presence of 1 of the following:
  • New lytic lesion
  • A 25% increase in urine or serum monoclonal protein
  • Patients who received prior bortezomib must have responded to therapy
  • Measurable disease, defined by 1 or more of the following criteria:
  • Serum M-component ≥ 1.0 g/dL by serum protein electrophoresis
  • Urine M-protein excretion \> 200 mg per 24-hour collection, by urine protein electrophoresis
  • Performance status - Karnofsky 60-100%
  • More than 8 weeks
  • Platelet count ≥ 100,000/mm\^3
  • Absolute neutrophil count ≥ 1,000/mm\^3
  • Bilirubin ≤ 2 mg/dL
  • Direct bilirubin ≤ 2 times upper limit of normal (ULN)
  • +36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomibtipifarnib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Darrin Beaupre

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

August 1, 2005

Primary Completion

February 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)