Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Fatigue

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Stimulants

All Drugs and Chemicals

Modafinil

Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

armodafinil

Placebo Comparator

Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

CBT-I

Joseph A Roscoe, PhD

This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.

Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized, controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least one month post treatment. The seven-week intervention is designed to determine the efficacy and acceptability of these treatment strategies in reducing insomnia in cancer survivors. Assessments will be made by questionnaires before, during, and two weeks following the study intervention. All ancillary treatments, as appropriate for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated.

Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data collection phase of the study, must have withdrawn from all sleep medications, including: prescription, over-the-counter, CAM and herbal remedies for at least one week prior to beginning the study.

CBT-I (Arms 3 \& 4): CBT-I will be provided on an individual basis to all patients in study Arms 3 \& 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in these two study arms will receive 7 weeks of CBT-I, using a structured research grade protocol developed at the UR-SNRL. This manualized intervention, which exists as a published text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy, Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy.

Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will be made to each participant not currently receiving CBT-I on each of these Fridays to promote compliance, prompt completion, assess potential side effects of study medication, and answer patient questions.

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.

The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue "now," and fatigue at its "worst" and "usual" for the last 24 hours. The 11-point scales are bounded by 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = "does not interfere" and 10 = "interferes completely." A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.

National Cancer Institute (NCI)

University of Rochester

Research Associate Professor

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Arm 1 - (CBT-I) + Placebo

Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

2 - CBT-I + Armodafinil

3- Placebo Only

Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

4 - Armodafinil Only

CBT-I and placebo

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

1 - CBT-I + Placebo

CBT-I + Armodafinil

armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Placebo only

Placebo Comparator: Placebo for 47 days

3 - Placebo Only

Armodafinil only

armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

Total

Age, Continuous

Gender

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Joseph A. Roscoe Ph.D.

Change in Insomnia Severity Index From Baseline to Post-intervention

Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.

Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Pazopanib

Placebo comparator

GSK Clinical Trials

This is a study to determine whether therapy with pazopanib is effective and safe in Asian women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has not progressed on first-line chemotherapy.

This study is an extension study to the VEG110655 study. The parent study, VEG110655, was designed to evaluate whether pazopanib 800 mg daily for 52 weeks will prolong progression free survival (PFS) in women diagnosed with ovarian, fallopian tube or primary peritoneal cancer. These women will have obtained stable disease, a complete remission, or a partial remission after debulking surgery and at least five cycles of chemotherapy (taxane/platinum). This extension study will evaluate safety and efficacy outcomes of pazopanib monotherapy and placebo in an Asian population with the same indication as the parent study.

Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women

A Study to Evaluate Efficacy and Safety of Pazopanib Monotherapy in Asian Women Who Have Not Progressed After First-line Chemotherapy for Advanced Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma - An Extension Study to VEG110655

PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.

Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.

PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as "Progressed per RECIST" if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as "Progressed per CA-125" if the radiological PD occurred after CA-125 progression. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.

Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.

An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.

Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg). A participant could have been counted in more than one shift category. Participants who experienced shifts in both SBP and DBP are represented under each individual parameter. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.

12-lead ECGs were obtained at the scheduled visits. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period. The QTc is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the faster the heart rate the shorter the QTc. If a QTc \>=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality. The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.

Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.

The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.

GlaxoSmithKline

Serious adverse events (SAEs) and non-serious AEs were collected in members of the All Treated Population, comprised of all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.

Participants received matching placebo administered orally once daily for up to 24 months.

Placebo

Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.

Pazopanib 800 Milligrams

Sex: Female, Male

Asian

Race/Ethnicity, Customized

GSK Response Center

Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012.

Progression-free Survival (PFS)

ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014.

Overall Survival

ITT Population. The cut off for these data was October 12, 2012.

PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria

Any Reduction

Any Interruption

All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.

Number of Participants With Any Dose Reduction or Any Dose Interruption

Any AE

Any SAE

All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.

Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)

Any on-therapy AE

Any AE related to study treatment

Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment

Number of Participants With Any Grade 3 or 4 AE

Hypertension, Grade 3

Neutropenia, Grade 3

Leukopenia, Grade 3

Diarrhea, Grade 3

ALT increased, Grade 3

Thrombocytopenia, Grade 3

AST increased, Grade 3

Neutrophil count decreased, Grade 3

Neutrophil count decreased, Grade 4

Arthralgia, Grade 3

Upper respiratory tract infection, Grade 3

Protein urine, Grade 3

Proteinuria, Grade 3

Bone pain, Grade 3

Toothache, Grade 3

Pyrexia, Grade 3

Hepatic function abnormal, Grade 3

Liver injury, Grade 3

Abdominal distension, Grade 3

Bradycardia, Grade 3

Febrile neutropenia, Grade 3

Thrombus in device, Grade 3

Pruritis, Grade 3

Amylase increased, Grade 3

Cerebral ischaemia, Grade 3

Foot fracture, Grade 3

Number of Participants With the Indicated On-therapy Grade 3-5 AEs

Permanent discontinuation

Dose interruption

Dose reduction

Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction

Any SAE related to study treatment

Any fatal SAE

Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE

SBP, Any increase to >=120 mmHg

SBP, Increase to 140-<160 mmHg

SBP, Increase to >=160 mmHg

DBP, Any increase to >=80 mmHg

DBP, Increase to 90-<100 mmHg

DBP, Increase to >=100 mmHg

All Treated Population. One participant on placebo did not report any blood pressure measurements post-Baseline. The cut off for these data was January 10, 2014.

Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline

Any increase to >=450 msec

Increase to 481-500 msec

Increase to >=501 msec

All Treated Population. Only those participants for which a post-Baseline ECG was conducted were analyzed. The cut off for these data was October 12, 2012.

Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)

Hemoglobin, AGI

Hemoglobin, ITG3

Hemoglobin, ITG4

Lymphocytes, AGI

Lymphocytes, ITG3

Lymphocytes, ITG4

Neutrophils, AGI

Neutrophils, ITG3

Neutrophils, ITG4

Platelets, AGI

Platelets, ITG3

Platelets, ITG4

White blood cells, AGI

White blood cells, ITG3

White blood cells, ITG4

All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy	NCT01091974	Insomnia Fatigue Breast Cancer	armodafinil Placebo Compara... CBT-I	21 Years - 75 Years	University of Rochester
Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women	NCT01227928	Neoplasms, Ovar...	Pazopanib Placebo compara...	18 Years -	GlaxoSmithKline
Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy	NCT00606970	Cancer	Seigen Alpha EV Placebo Compara...	18 Years - 75 Years	New Hope Medical Center
Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women	NCT01227928	Neoplasms, Ovar...	Pazopanib Placebo compara...	18 Years -	GlaxoSmithKline
Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy	NCT00606970	Cancer	Seigen Alpha EV Placebo Compara...	18 Years - 75 Years	New Hope Medical Center
Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy	NCT00606970	Cancer	Seigen Alpha EV Placebo Compara...	18 Years - 75 Years	New Hope Medical Center
A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma	NCT00502307	Carcinoma, Rena...	Tivozanib (AV-9... Placebo compara...	18 Years -	AVEO Pharmaceuticals, Inc.
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer	NCT01717482	Lung Neoplasms Carcinoma, Non-...	Metformin Placebo Compara...	18 Years -	Mayo Clinic
Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy	NCT00676507	Lung Neoplasm Carcinoma Non-s... Carcinoma Non-s... Carcinoma Non-s...	Lucanix™ Placebo Compara...	18 Years - 75 Years	NovaRx Corporation
Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.	NCT02223078	Colorectal Canc...	G17DT Placebo Compara...	18 Years - 90 Years	Cancer Advances Inc.
Ritalin: Antiasthenic Effect of Methylphenidate (Ritalin) in Palliative Care in Cancer Patients	NCT00273741	Asthenia Neoplasms	methylphenidate placebo compara...	18 Years - 75 Years	University Hospital, Grenoble

Spots Global Cancer Trial Database for placebo comparator