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
  Purpose

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.


Condition Intervention Phase
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Fatigue
Drug: armodafinil 150 mg
Other: Placebo
Drug: armodafinil 250 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 330
Study Start Date: June 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 150 mg
given orally
Placebo Comparator: Arm II
Patients receive placebo orally everyday in the morning for 8 weeks.
Other: Placebo
given orally
Experimental: Arm III
Patients receive 250 mg armodafinil orally everyday in the morning for 8 weeks.
Drug: armodafinil 250 mg
given orally

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781468

  Show 92 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Alyx B. Porter Umphrey, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01781468     History of Changes
Other Study ID Numbers: A221101, N10C3, NCI-2012-02020, U10CA031946
Study First Received: January 29, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Signs and Symptoms
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 30, 2014