NCT00276302

Brief Summary

The primary objectives of the study are:

  • Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies
  • Recommend a dose for subsequent studies of IPI-504

Trial Health

90
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_1

Geographic Reach
2 countries

5 active sites

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

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

4.9 years

First QC Date

January 11, 2006

Last Update Submit

January 5, 2011

Conditions

Gastrointestinal Stromal TumorsSoft Tissue Sarcomas

Outcome Measures

Primary Outcomes (2)

  • To determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies

    18 months

  • To recommend a dose for subsequent studies of IPI-504

    18 months

Secondary Outcomes (3)

  • To examine the pharmacokinetic (PK) parameters of IPI-504 in GIST and STS patients

    18 months

  • To assess in a preliminary way the potential anti-tumor activity of IPI-504 in GIST and STS.

    18 months

  • To explore potential pharmacodynamic (PD) markers of biologic activity of IPI-504 in GIST and STS.

    18 months

Study Arms (2)

1

EXPERIMENTAL

Schedule A: Doses occur on Days 1, 4, 8, and 11 followed by 10 days with no study drug administration.

Drug: IPI-504

2

EXPERIMENTAL

Schedule B: Doses occur on Days 1, 4, 8, 11, 15, and 18 (twice weekly for 3 weeks continuously).

Drug: IPI-504

Interventions

IPI-504DRUG

IV administration of IPI-504 for 21-day cycles. Two different schedules of treatment will be tested. On Schedule A, doses occur on Days 1, 4, 8, and 11 followed by 10 days with no study drug administration. On Schedule B, doses occur on Days 1, 4, 8, 11, 15, and 18, or twice weekly for 3 weeks continuously. For both Schedule A and B doses will be administered ≥ 72 hours apart.

12

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed diagnosis of GIST or STS
  • Failed prior therapies
  • ECOG performance status of 0-2
  • Ability to adhere to the study visit schedule and all protocol requirements

You may not qualify if:

  • Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor
  • Participation in any investigational drug study or treatment with any other kinase inhibitor therapy within 2 weeks preceding start of treatment
  • Concurrent radiation therapy is not permitted
  • Concurrent treatment with any agent that alters CYP3A activity
  • Concurrent treatment with any agent that may prolong the QTc interval
  • Myocardial infarction or active ischemic heart disease within 6 months
  • History of arrhythmia
  • Baseline QTc \>450
  • Grade 3 or greater peripheral neuropathy
  • Renal insufficiency, serum creatinine \>1.5 x ULN
  • Platelets \< 100,000 mm3
  • AST and / or ALT \> 2.5 x ULN
  • ANC \<1,500 cells/mm3
  • Alkaline phosphatase \> 2.5 x ULN
  • Amylase and lipase \> 1.5 x ULN
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Premiere Oncology

Scottsdale, Arizona, 85260, United States

Location

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Hosptials

Ann Arbor, Michigan, 48109, United States

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Stromal TumorsSarcoma

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • George D Demetri, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 13, 2006

Study Start

December 1, 2005

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

US(4)CA(1)