NCT00606814

Brief Summary

This study is a Phase I clinical trial of IPI-504 in combination with docetaxel (Taxotere).The purposes of the study are to determine:

  • the safety profile,
  • the highest dose of IPI-504 that can be given with docetaxel without causing severe side effects, and
  • to recommend a Phase II dose of the combination in patients with solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_1

Geographic Reach
1 country

8 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, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

3.4 years

First QC Date

January 22, 2008

Last Update Submit

March 2, 2012

Conditions

Solid Tumors

Keywords

Solid Tumors, IPI-504, docetaxel,cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the safety, maximum tolerated dose(MTD)of IPI-504 in combination with docetaxel in patients with advanced solid tumors and recommend the Phase II dose of the combination of drugs.

    Weekly

Secondary Outcomes (2)

  • To determine the pharmacokinetics (PK) and response rate (CR+PR) for patients with measurable lesions (as determine by RECIST)

    Weekly

  • To determine the pharmacokinetics (PK) of IPI-504 and docetaxel

    Weekly

Interventions

IPI-504, docetaxelDRUG

1. IPI-504 administered IV at a dose of 300mg/m2 2. Docetaxel at a fixed dose of 75 mg/m2 for every 3 weeks dose administration or 36 mg/m2 for weekly administration

Also known as: Taxotere

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed malignancy that is metastatic or unresectable, for which one of the two statements must apply:
  • Standard therapy able to provide clinical benefit does not exist or is no longer effective AND / OR
  • Single agent docetaxel would be appropriate therapy.
  • Progressive disease with development of new lesions or an increase in preexisting lesions on CT, MRI, PET, bone scintigraphy, or by physical examination.
  • Measurable disease by RECIST criteria with the exception of prostate cancer patients.
  • \>18 years of age at the time of signing the Informed Consent Form (ICF) and have a life expectancy of at least 3 months.
  • Karnofsky performance status of 70 or better.
  • Adhere to the study visit schedule
  • Voluntarily sign the Informed Consent Form (ICF).
  • Baseline studies completed within 30 days of first study dose.
  • Women of child-bearing potential (WCBP) defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months must have a negative serum or urine pregnancy test within 2 weeks of first study dose and prior to each additional cycle of treatment.
  • All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study
  • Must have archival NSCLC tissue available for submission and analysis.

You may not qualify if:

  • Treatment within 1 week of the start of IPI-504 for erlotinib, and imatinib; within 2 weeks for gefitinib, and any other tyrosine kinase inhibitor (approved or investigational); within 4 weeks for any biologic therapy (antibody, vaccine, or other protein-based therapy), radiation therapy, or conventional chemotherapy; within 6 weeks for nitrosoureas or mitomycin C.
  • Radiation therapy within 2 weeks of the start of IPI-504. (Patients must have recovered from any toxicities.)
  • Concurrent radiation therapy or treatment with any other investigational agent is not permitted.
  • Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to Cycle 1, Dose 1.
  • Symptomatic peripheral neuropathy ≥ Grade 2.
  • Inadequate hematologic function defined by absolute neutrophil count (ANC) \<1,500 cells/mm3, a platelet count \<100,000/mm3, and a hemoglobin \<9.0 g/dL (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
  • Inadequate renal function defined by AST and/or ALT \>1.5; total bilirubin above the upper limit of normal.
  • Inadequate renal function defined by serum creatinine \>1.5 x ULN.
  • Sinus bradycardia (resting heart rate \<50) secondary to intrinsic conduction system disease. Patients with sinus bradycardia secondary to pharmacologic treatment may enroll if withdrawal of the treatment results in normalization of the resting heart rate to within normal limits.
  • Baseline QTc \>450 msec in males; QTc \>470 msec in females, or previous history of QT prolongation while taking other medications.
  • Presence of left bundle branch block, right bundle branch block plus left anterior hemiblock, bifasicular block or 3rd degree heart block. This does not include patients with a history of these events with adequate control by pacemaker.
  • Patients who have received \>450 mg/m2 of any anthracycline during prior chemotherapy must have a baseline LVEF \>40%.
  • Active keratitis or keratoconjunctivitis.
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  • Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

TGen Clinical Research in Scottsdale

Scottsdale, Arizona, 85258, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06519, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10066, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Gabrail Cancer Center

Dover, Ohio, 44622, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

tanespimycinDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Gregory Riely, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

December 1, 2007

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

US(8)