Trial Outcomes & Findings for Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents (NCT NCT00825227)

Last Updated: 2017-11-17

Results Overview

Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)

Results posted on

2017-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	150 mg/Day Armodafinil * 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents	Matching Placebo * placebo * taxane chemotherapy treatment alone or in combination with other agents
Overall Study STARTED	6	4
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150 mg/Day Armodafinil n=6 Participants * 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents	Matching Placebo n=4 Participants * placebo * taxane chemotherapy treatment alone or in combination with other agents	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	59.5 years STANDARD_DEVIATION 3.73 • n=5 Participants	56.5 years STANDARD_DEVIATION 5.80 • n=7 Participants	58.3 years STANDARD_DEVIATION 4.62 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)

Population: Study was discontinued after only 6 subjects were enrolled due to a business decision, so no outcome analysis was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of up to 8 weeks total (Screening and Double-Blind)

Population: This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.

The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of up to 8 weeks total (Screening and Double-Blind)

Population: This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.

The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.

Outcome measures

Outcome data not reported

Adverse Events

150 mg/Day Armodafinil

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Matching Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	150 mg/Day Armodafinil n=6 participants at risk * 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents	Matching Placebo n=4 participants at risk * placebo * taxane chemotherapy treatment alone or in combination with other agents
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease Progression (Prostate Cancer) / Prostate Cancer	0.00% 0/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Number of events 1 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Nervous system disorders Syncope	16.7% 1/6 • Number of events 1 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Ileus	16.7% 1/6 • Number of events 1 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Infections and infestations Urinary Tract Infection	16.7% 1/6 • Number of events 1 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.

Other adverse events

Additional Information

Vice President, Clinical Research

Cephalon, Inc.

Phone: 1-800-896-5855

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	150 mg/Day Armodafinil n=6 participants at risk * 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents	Matching Placebo n=4 participants at risk * placebo * taxane chemotherapy treatment alone or in combination with other agents
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Cardiac disorders Tachycardia	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Abdominal pain lower	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	50.0% 2/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Nausea	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Gastrointestinal disorders Stomatitis	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
General disorders Chest discomfort	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
General disorders Chest pain	0.00% 0/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
General disorders Chills	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Infections and infestations Tooth abscess	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Injury, poisoning and procedural complications Humerus fracture	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Investigations International normalised ratio increased	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Investigations Prothrombin time prolonged	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Investigations Skin turgor decreased	0.00% 0/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Metabolism and nutrition disorders Anorexia	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Psychiatric disorders Depression	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Psychiatric disorders Insomnia	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Skin and subcutaneous tissue disorders Skin lesion	16.7% 1/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	0.00% 0/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Vascular disorders Hypertension	0.00% 0/6 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.	25.0% 1/4 • Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.