Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00087685 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

RAD001 in Recurrent Endometrial Cancer Patients

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    3 amendments

    3 re-verifications since 2023-10-11, no change to tracked fields

    v20-v22

  2. Notable

    Results first posted: Feb 5, 2016

    Primary endpoints: 1 to 2; Completion date: Jan 2015

    Show what changed: Primary endpoints
    Clinical Benefit Rate Number of Participants With Objective Response plusPlus Stable Disease Rate (CR + PR + SD)

    Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv19

  3. Notable

    Primary endpoint revised

    Trial status: Active, Not Recruiting to Completed; Primary completion date changed from estimate of Jun 2015 to Jan 2015; Eligibility criteria expanded, about 4 words; and 2 more

    Show all 6 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      ToObjective learnResponse ifplus RAD001Stable canDisease shrinkRate or(CR slow+ thePR growth+ of tumors in patients who have recurrent endometrial cancer.SD)
    • Minor Trial status: Active, Not Recruiting to Completed
    • Minor Primary completion date changed from estimate of Jun 2015 to Jan 2015
    • Minor Eligibility criteria expanded, about 4 words
      Show what changed
      [...] ia: Patients who have previously received RAD001 or another mammalian target of rapamycin (mTOR) inhibitor. Patients whose tumors have serous carcinomas, mi [...]
    • Minor Secondary endpoints shortened, about 9 words
      Show what changed
      The safety of this drug will also be studied.
    • Minor Study site revised
      Show what changed
      UTUniversity of Texas MD Anderson Cancer Center

    Study Identification, Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations, Referencesv18

  4. Notable

    Primary completion date: Jun 2014 to Jun 2015

    Study Statusv17

  5. Notable

    Primary completion date: Jun 2013 to Jun 2014

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] or excipients including hydroxytoluene, magnesium stearate, hydroypropylmethylhydroxypropylmethyl-cellulose, crospovidone and lactulose.

    Study Status, Arms and Interventions, Eligibilityv16

Show 14 earlier versions

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v15

  2. Minor

    Eligibility criteria revised

    Study description shortened, about 2 words

    Show what changed: Eligibility criteria
    [...] dy entry. Patients with >/= grade 2 hypercholesterolemia or hypertriglyceridemiahypertriglyceridaemia (fasting state), despite lipid lowering therapy should be e [...]
    Show what changed: Study description
    [...] sease) to evaluate the response of your tumor to treatment. and . These scans will be done after the first two courses (eight [...]

    Study Status, Study Description, Study Design, Eligibility, Contacts/Locationsv14

  3. Notable

    Primary completion date: Jun 2012 to Jun 2013

    Study Status, Sponsor/Collaboratorsv13

  4. Notable

    Primary completion date: Jun 2011 to Jun 2012

    Study Statusv12

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v11

  6. Notable

    Primary completion date: Dec 2008 to Jun 2011

    Study site revised

    Show what changed: Study sites
    U.T.M.D.UT MD Anderson Cancer Center

    Study Status, Contacts/Locationsv10

  7. Minor

    Primary completion date: Jun 2008 to Dec 2008

    Study Status, Referencesv9

  8. Notable

    Primary endpoint revised

    Trial status: Recruiting to Active, Not Recruiting; Study description shortened, about 9 words; Site details revised

    Show what changed: Primary endpoints
    The goal of this clinical research study is toTo learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer.
    Show what changed: Study description
    [...] 01 has been authorized by the FDA for use in research only. The study drug will be provided free of charge. Up to 35 patients will take part in this study. All will be enrolled at M. D. Anderson.

    Study Status, Study Description, Outcome Measures, Contacts/Locationsv8

  9. Minor

    Primary completion date: Jun 2008

    Eligibility criteria revised; Study arms: 0 to 1

    Show what changed: Eligibility criteria
    [...] or excipients including hydroxytoluene, magnesium stearate, hydroxypropylmethylhydroypropylmethyl-cellulose, crospovidone and lactulose.

    Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measures, Eligibilityv7

  10. Minor

    Study Status, Study Description, Study Design

    Re-verified, no change to tracked fields

    v6

  11. Minor

    Eligibility criteria revised

    Study description expanded, about 416 words; Study site revised; Collaborators shortened, about 1 word; and 1 more

    Show all 5 changes in this update
    • Minor Eligibility criteria revised
      Show what changed
      [...] s may have failed no more than two prior chemotherapies for the recurrent disease (does not include chemosensitizing radiati [...] easurable disease. Measurable disease is defined as lesions whichthat can be measured by physical examination or by means of imag [...] dered measurable disease. Patients must have a pretreatment absolute granulocyte count (i.e., segmented neutrophils + bands) of >/=1,500/Fl, a hemoglobin [...] cinomas, mixed malignant mullerian tumors (MMMT) components andor uterine sarcomas. Patients who have isolated recurrences (vaginal, pelvic, or paraaorticpara-aortic) that are amenable to poten [...] [...]
    • Minor Study description expanded, about 416 words
      Show what changed
      RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer. Before treatment starts, you will have a complete physical exam, routine blood tests (about 2-3 teaspoons), a chest x-ray, and a CT scan or MRI of the abdomen and pelvis. Women who ar [...]
    • Minor Study site revised
      Show what changed
      University of Texas U.T.M.D. Anderson Cancer Center
    • Minor Collaborators shortened, about 1 word
      Show what changed
      Novartis
    • Minor Study title expanded, about 1 word
      Show what changed
      RAD001 in Recurrent Endometrial Cancer Patients

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Eligibility, Contacts/Locationsv5

  12. Minor

    2 amendments

    2 re-verifications since 2006-05-05, no change to tracked fields

    v3-v4

  13. Minor

    Eligibility criteria shortened, about 1 word

    Show what changed: Eligibility criteria
    [...] dy entry. Patients with >/= grade 2 hypercholesterolemia or hypertrilyceridemia hypertriglyceridemia(fasting state), despite lipid lowering therapy should be ex [...]

    Study Identification, Study Status, Eligibilityv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer. The safety of this drug will also be studied. Objectives: Primary Objective: 1\. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer. Secondary Objective: 1. To determine the nature and degree of toxicity of RAD001 in this cohort of patients. 2. To characterize, in pre- and post- treatment tumor samples, when available, expression levels of total and phosphorylated mTOR (mammalian "target of rapamycin") as well as relevant upstream and downstream signaling components (optional).
Trial Details
NCT Number NCT00087685
Lead Sponsor M.D. Anderson Cancer Center
Conditions Endometrial Cancer
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov