NCT00087451

Brief Summary

A Phase I, open-label, non-randomized, sequential dose escalation cohort trial of the safety, tolerability, and maximum tolerated dose (MTD) of AP23573 when administered intravenously as a 30-minute infusion, once daily for five days, repeated every two weeks, to patients with progressive or recurrent malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

4 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

July 1, 2004

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

July 8, 2004

Last Update Submit

August 18, 2015

Conditions

Malignant GliomaGlioblastomaGliosarcoma

Keywords

Progressive or recurrent malignant glioma

Interventions

AP23573DRUG

ridaforolimus

Also known as: deforolimus, MK-8669, ridaforolimus was also known as deforolimus until May 2009

Eligibility Criteria

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

You may qualify if:

  • Male or female patients ≥ 18 years of age
  • Patients must have a radiographically suspected progressive or recurrent primary malignant glioma (glioblastoma multiforme or gliosarcoma) and must have failed standard therapy. Patients may not have received any systemic therapy for the treatment of this recurrence or relapse
  • Patients must be candidates for surgical resection or open biopsy of the tumor
  • Patients who have had previous surgical resection(s) are eligible
  • Patients must have had minimum prior therapy of radiotherapy and documented progression of disease thereafter
  • Patients must have had a tissue proven malignant glioma
  • A minimum interval of at least four weeks prior to the first dose of AP23573 must have elapsed for all patients enrolling after either prior surgery or completion of prior external beam radiotherapy for initial primary diagnosis
  • A minimum interval of four weeks prior to the first dose of AP23573 must have elapsed since receipt of any investigational therapy or any other chemotherapy
  • Patients in the EIAC cohorts must be presently receiving a stable dose of EIAC (e.g., dilantin, phenytoin, etc.) for at least two weeks prior to the first dose of AP23573
  • For patients on corticosteroids, the dose must be stable for at least one week prior to the first dose of AP23573
  • Patients must be neurologically stable for at least two weeks prior to the first dose of AP23573
  • Patients must have an ECOG performance status of 0 or 1
  • Patients must either not be of childbearing potential or have agreed to use a medically effective method of contraception
  • Patients must have adequate hematologic, renal and liver function as specified in the protocol
  • Patients must be able to understand and give written informed consent

You may not qualify if:

  • Women who are pregnant or lactating
  • Patients with known or suspected hypersensitivity to either drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug formulation
  • Patients with known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
  • Patients with significant cardiovascular disease, as specified in the protocol
  • Patients with known HIV infection
  • Patients with any active infection requiring prescribed intervention
  • Patients receiving immunosuppressive agents other than prescribed corticosteroids
  • Patients who have had prior therapy with rapamycin, any rapamycin analog or tacrolimus
  • Patients with inadequate recovery from any prior surgical procedure or patients having undergone any major surgical procedure within two weeks prior to the first dose of AP23573
  • Patients with any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug
  • Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
  • Patients with another primary malignancy within the past three years (except for non-melanoma skin cancers and cervical carcinomas in situ)
  • Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements
  • Patients are not permitted any chemotherapeutic agents or other antineoplastic agents either during or within four weeks prior to the first dose of AP23573. Additional excluded drugs and treatments are specified in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center For Neuro-Oncology, Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

The Brain Tumor Center at Duke, Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Brain Tumor Institute, The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Reardon DA, Wen PY, Alfred Yung WK, Berk L, Narasimhan N, Turner CD, Clackson T, Rivera VM, Vogelbaum MA. Ridaforolimus for patients with progressive or recurrent malignant glioma: a perisurgical, sequential, ascending-dose trial. Cancer Chemother Pharmacol. 2012 Apr;69(4):849-60. doi: 10.1007/s00280-011-1773-y. Epub 2011 Oct 30.

    PMID: 22037923RESULT

MeSH Terms

Conditions

GliomaGlioblastomaGliosarcoma

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytoma

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

July 8, 2004

First Posted

July 13, 2004

Study Start

July 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

US(4)