NCT00060632

Brief Summary

Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of ridaforolimus in patients with refractory or recurrent malignancies, including myeloma and lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2003

Typical duration for phase_1

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

April 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

May 8, 2003

Last Update Submit

August 26, 2015

Conditions

TumorsLymphomaMultiple Myeloma

Keywords

Advanced, refractory or recurrent solid tumors

Outcome Measures

Primary Outcomes (3)

  • Maximum Tolerated Dose (MTD)

    Cycle 1 (within the first 4 weeks)

  • Number of Participants Reporting Adverse Events (AE)

    Throughout study duration and up to approximately 1 month after the last dosing cycle (Cycle 1 Day 1 to approximately 10 months)

  • Number of Participants Discontinuing Due to AEs

    Throughout study duration (Cycle 1 Day 1 to approximately 9 months)

Secondary Outcomes (7)

  • Best Overall Tumor Response

    8 weeks

  • Maximum Concentration (Cmax) of Ridaforolimus

    Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1

  • Area Under the Curve (AUC[0 to Infinity]) of Ridaforolimus

    Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1

  • Apparent Terminal Half-Life (t1/2) of Ridaforolimus

    Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1

  • Clearance (CL) of Ridaforolimus

    Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1

  • +2 more secondary outcomes

Study Arms (6)

Cohort 1: Ridaforolimus 6.25 mg

EXPERIMENTAL
Drug: ridaforolimus

Cohort 2: Ridaforolimus 12.5 mg

EXPERIMENTAL
Drug: ridaforolimus

Cohort 3: Ridaforolimus 25 mg

EXPERIMENTAL
Drug: ridaforolimus

Cohort 4: Ridaforolimus 50 mg

EXPERIMENTAL
Drug: ridaforolimus

Cohort 5: Ridaforolimus 100 mg

EXPERIMENTAL
Drug: ridaforolimus

Cohort 6: Ridaforolimus 75 mg

EXPERIMENTAL
Drug: ridaforolimus

Interventions

ridaforolimusDRUG

Administered intravenously once weekly for 4 weeks (1 cycle). In the absence of disease progression or unacceptable toxicity, patients could continue to receive additional cycles.

Also known as: AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
Cohort 1: Ridaforolimus 6.25 mgCohort 2: Ridaforolimus 12.5 mgCohort 3: Ridaforolimus 25 mgCohort 4: Ridaforolimus 50 mgCohort 5: Ridaforolimus 100 mgCohort 6: Ridaforolimus 75 mg

Eligibility Criteria

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

You may qualify if:

  • (Patients must meet each of the following criteria to be eligible for participation in the study).
  • Male or female patients, ≥ 18 years of age.
  • Patients with a documented measurable or evaluable malignancy, including myeloma or lymphoma, that is recurrent, advanced, or metastatic.
  • Patients with disease that is currently refractory to, or not amenable to, standard therapy.
  • Patients with disease that is currently not amenable to surgical intervention.
  • Patients with Karnofsky performance status of ≥ 70% (Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1) and an anticipated life expectancy of ≥ 3 months.
  • Patients either not of childbearing potential, or agreeing to use a medically effective method of contraception.
  • Patients with the ability to understand and give written informed consent.

You may not qualify if:

  • (Patients meeting any of the following criteria are ineligible for participation in the study)
  • Women who are pregnant or lactating.
  • Patients with primary central nervous system (CNS) malignancies. Patients with leukemia, any form.
  • Patients with certain hematologic abnormalities.
  • Patients with certain serum chemistry abnormalities at baseline.
  • Patients with known or suspected hypersensitivity to either drugs formulated with polysorbate 80 (Tween 80) or any other excipient contained in the test drug formulation.
  • Patients with known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin).
  • Patients with significant cardiovascular disease.
  • Patients with active CNS metastases (or leptomeningeal disease) not controlled by prior surgery or radiotherapy. Note: Patients with treated brain metastases will be eligible if they are on a stable dose of corticosteroids or are without change in brain disease status for at least 4 weeks following related therapy (e.g., whole brain radiation, surgery).
  • Patients with known human immunodeficiency virus (HIV) infection.
  • Patients with any active infection.
  • Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 2 weeks prior to study entry. Note: Patients having undergone recent placement of a central venous access port will be considered eligible for enrollment if they have recovered.
  • Patients who have 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 test 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 the inability, in the opinion of the Investigator, to comply with the protocol requirements.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hartford CM, Desai AA, Janisch L, Karrison T, Rivera VM, Berk L, Loewy JW, Kindler H, Stadler WM, Knowles HL, Bedrosian C, Ratain MJ. A phase I trial to determine the safety, tolerability, and maximum tolerated dose of deforolimus in patients with advanced malignancies. Clin Cancer Res. 2009 Feb 15;15(4):1428-34. doi: 10.1158/1078-0432.CCR-08-2076.

    PMID: 19228743BACKGROUND

MeSH Terms

Conditions

NeoplasmsLymphomaMultiple Myeloma

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

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

May 8, 2003

First Posted

May 12, 2003

Study Start

April 1, 2003

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

August 27, 2015

Record last verified: 2015-08