Trial record 1 of 1 for:    A221101
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Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01781468
First received: January 29, 2013
Last updated: April 11, 2014
Last verified: April 2014

January 29, 2013
April 11, 2014
June 2013
March 2016   (final data collection date for primary outcome measure)
Response rate in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01781468 on ClinicalTrials.gov Archive Site
  • Fatigue: Brief Fatigue Inventory (BFI), Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the summated score from the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Cognitive function: As Assessed by Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association, Trail Making Test, and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life as measured by Linear Analogue Self Assessment (LASA) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients reporting adverse events via the CTCAE version 4.0 items [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Fatigue: Brief Fatigue Inventory (BFI), Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the summated score from the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Cognitive function: As Assessed by Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association, Trail Making Test, and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life as measured by Linear Analogue Self Assessment (LASA) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients reporting adverse events via the CTCAE version 4.0 items [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.

Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue (Brief Fatigue Inventory - BFI) at 8 weeks of two doses (150 mg and 250 mg of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.

The secondary objectives of the study are listed below.

  1. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
  2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with glioblastoma.
  3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints (i.e. usual fatigue, activity interference) in this patient population with high grade glioma.
  4. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as the relationship of fatigue and cognitive difficulties.

Patients will receive armodafinil or placebo for a total of 8 weeks.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Fatigue
  • Drug: armodafinil 150 mg
    given orally
  • Other: Placebo
    given orally
  • Drug: armodafinil 250 mg
    given orally
  • Experimental: Arm I
    Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
    Intervention: Drug: armodafinil 150 mg
  • Placebo Comparator: Arm II
    Patients receive placebo orally everyday in the morning for 8 weeks.
    Intervention: Other: Placebo
  • Experimental: Arm III
    Patients receive 250 mg armodafinil orally everyday in the morning for 8 weeks.
    Intervention: Drug: armodafinil 250 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
Not Provided
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosed with glioblastoma multiforme, anaplastic astrocytoma, gliosarcoma, or anaplastic oligodendroglioma who are clinically stable and have completed radiation therapy > 21 days and ≤ 24 months prior to enrollment. NOTE: Clinical stability will be defined as a stable or improved Karnofsky Performance Status (KPS) compared to the prior month.
  • ≥ 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory)
  • Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma anaplastic astrocytoma, or anaplastic oligodendroglioma patients.

Note: Radiation must be completed per the second eligibility criteria, but chemotherapy is allowed.

  • Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only, per physician discretion
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, 2 or 3
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
* Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • Stable dose of corticosteroid ≤ 28 days prior to registration

Exclusion Criteria:

  • Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown in pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception
  • History of hypersensitivity to other psychostimulants
  • History of steroid psychosis
  • History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self report
  • Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc. will be excluded; Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plans to continue for the duration of the trial;
 erythropoietin agents to treat anemia are allowed; exercise is allowed
  • Anticipating surgery, laboratory evidence of hypothyroidism with an elevated thyroid stimulating hormone (TSH) concentration in the blood > 5.0 mlU/L, profound anemia (hemoglobin level of < 10 g/dL) ≤ 28 days prior to registration, and clinical depression per physician discretion
  • Active or a history of Tourette syndrome or tic disorder
  • History of or active glaucoma
  • History of intractable epilepsy, or uncontrolled seizure disorder
  • Any of the following co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens:

    1. History of myocardial infarction
    2. Unstable angina
    3. Left ventricular hypertrophy
    4. Mitral valve prolapse syndrome
  • Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 3A4 (CYP3A4); use of the following strong or moderate inhibitors are prohibited ≤ 7 days prior to registration:

    1. Strong Inhibitors of CYP3A4:
 > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance
:

      1. Indinavir (Crixivan®)

      2. Nelfinavir (Viracept®)

      3. Atazanavir (Reyataz®)

      4. Ritonavir (Norvir®)

      5. Clarithromycin (Biaxin®, Biaxin XL®)

      6. Itraconazole (Sporanox®)

      7. Ketoconazole (Nizoral®)

      8. Nefazodone (Serzone®)

      9. Saquinavir (Fortovase®, Invirase®)

      10. Telithromycin (Ketek®)

    2. Moderate Inhibitors of CYP3A4
: > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance
:

      1. Aprepitant (Emend®)
      2. Erythromycin (Erythrocin®, E.E.S. ®, Ery-Tab®, Eryc®, EryPed®, PCE®
)
      3. Fluconazole (Diflucan®)

      4. Grapefruit juice

      5. Verapamil (Calan®, Calan SR®, Covera-HS®, Isoptin SR®, Verelan®, Verelan PM®)
      6. Diltiazem (Cardizem®, Cardizem CD®, Cardizem LA®, Cardizem SR®, Cartia XT™) Dilacor XR®, Diltia XT®, Taztia XT™, Tiazac®)
  • Receiving any medications or substances that are inducers of CYP3A4; use of the following inducers are prohibited ≤ 7 days prior to registration:


    1. Inducers of CYP3A4

      1. Efavirenz (Sustiva®)

      2. Nevirapine (Viramune®)

      3. Carbamazepine (Carbatrol®, Epitol®, Equetro™)
      4. Tegretol®, Tegretol-XR®)

      5. Modafinil (Provigil®)

      6. Phenobarbital (Luminal®)

      7. Phenytoin (Dilantin®, Phenytek®)

      8. Pioglitazone (Actos®)

      9. Rifabutin (Mycobutin®)

      10. Rifampin (Rifadin®)
      11. St. John's Wort
Both
18 Years and older
No
United States
 
NCT01781468
A221101, N10C3, NCI-2012-02020, U10CA031946
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Alyx B. Porter Umphrey, M.D. Mayo Clinic
Alliance for Clinical Trials in Oncology
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP