MDACC Study Summary 2006-0968 (Archived)

Study Summary
No. 2006-0968:.......Pain......Allen W. Burton......Anesthesiology

Study Summary Title



Study Summary Number:	2006-0968

Study Title:	An Open-Label Study Investigating Long-Term Safety and Tolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Physician

New Patient Referral



Name:	Allen W. Burton	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Anesthesiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-7246 Contact us about clinical trials

General Information



Disease Group:	Pain	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	All subjects will come to the study centre for up to 8 visits. The total duration of individual subject participation is up to approximately 5 months.

Treatment Agents:	Fentanyl Citrate	Home Care:	subjects newly enrolled: Open, Dose-Titration Phase: Nasalfent 100 to 800 mcg Open-Label Treatment Phase: Nasalfent 100, 200, 400, or 800 mcg subjects previously enrolled in Study CP043/06/FCNS or CP044/06/FCNS: Nasalfent 100, 200, 400, or 800 mcg

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	No required hospital stay.


Description/ Intervention:	The goal of this clinical research study is to learn if Nasalfent (fentanyl citrate nasal spray) can help to relieve pain in patients with breakthrough cancer pain. The safety and side effects of intranasal fentanyl citrate will also be studied.

Study Objectives / Outcomes

The primary objective of the study is to investigate the long-term safety, tolerability, and acceptability of Nasalfent in the treatment of BTCP.

Study Status Information



Study Activation / Registration Date:	09/18/2007

IRB Review and Approval Date:	06/29/2007

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	500

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) EITHER The subject was previously enrolled in Studies CP043/06/FCNS or CP044/06/FCNS and: a. Successfully completed the study (including the return of any remaining drug supplies and successful completion of the subject diaries). b. Continues to experience episodes of breakthrough pain that were adequately controlled with a designated dose of Nasalfent in Studies CP043/06/FCNS or CP044/06/FCNS.

2) (Cont#1):c. The subject's medical condition is such that the subject continues to meet the other inclusion/exclusion criteria listed below. OR The subject has not participated in Studies CP043/06/FCNS or CP044/06/FCNS and wishes to participate in this study (CP045/06/FCNS).

3) Subjects who are able and willing to provide written informed consent.

4) Male or female subjects, 18 years of age and older.

5) If female, and of childbearing potential (not surgically sterile or </=1 year after the onset of amenorrhea due to menopause), must (a) have a negative serum pregnancy test, (b) not be lactating, and (c) agree to practice a reliable form of contraception or abstinence during the study.

6) Subjects who have a histologically documented diagnosis of a malignant solid tumor or a hematological malignancy causing cancer-related pain.

7) Subjects who are taking at least 60 mg oral morphine or equivalent for at least 1 week for cancer-related pain as regular, 24-hour medication for their underlying persistent cancer pain.

8) Subjects who are experiencing, on average, but not necessarily every day, 1 to 4 episodes of BTCP per day that are adequately controlled with a stable dose of standard rescue medication, typically a fast-acting opioid, of which the subject should have an adequate supply throughout the study. Breakthrough pain is defined as a transitory flare of moderate to severe pain (on a 4-point scale from 0 to 3 [none, mild,

9) (Cont#8):moderate, severe] as defined by the Breakthrough Pain Questionnaire that occurs on a background of persistent pain controlled to moderate intensity or less by the opioid regimen. If the subject has more than 1 type of breakthrough pain, or has breakthrough pain in more than 1 location, only 1 of the pains will be identified as a "target" breakthrough pain.

10) Subjects who, in the opinion of the investigator, are willing and able (personally or with the help of a caregiver) to a. Evaluate and record pain intensity and pain relief. b. Assess medication performance at specific times after dosing. c. Record AEs. d. Record each instance of the use of study drug and standard rescue medication in a subject diary for the duration of the study.

11) Subjects with an Eastern Cooperative Oncology Group (ECOG) score of </=2 and a life expectancy which, in the opinion of the investigator, will allow them to participate for the duration of the study.

Exclusion Criteria:

1) Subjects with an opioid or fentanyl intolerance.

2) Subjects with uncontrolled or rapidly escalating pain.

3) Subjects using intrathecal or epidural opioids.

4) Subjects whose condition is unstable or rapidly deteriorating, such that they are (in the opinion of the investigator) unlikely to be able to make an effective contribution to the study.

5) Subjects with sleep apnea or active brain metastases with increased intracranial pressures.

6) Subjects with any respiratory or cardiac condition that, in the opinion of the investigator, may be worsened by opioids.

7) Subjects with any other medical condition that, in the judgment of the investigator, would confound the objectives of the study.

8) Subjects with a recent history of alcohol or substance abuse that would compromise data collection.

9) Subjects with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection.

10) Subjects with clinically significant renal and hepatic dysfunction test results at Screening outside the following limits: a. Serum creatinine must be </=2.0 mg/dL, or creatinine clearance calculated by Cockcroft-Gault formula must be>/=50 mL/min. b. Serum total bilirubin must be </=2.0 mg/dL.Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase must be </=3 times the upper limit of normal (</=5 times the upper limit of normal if due to liver metastases).

11) Subjects taking any medication likely to affect the physiology of the nasal mucosa.

12) Any abnormal nasal physiology and/or pathology which, in the opinion of the investigator, would not allow the objectives of the study to be accomplished.

13) Subjects with known intolerance to nasal sprays and/or pharmaceutical materials found in the investigational products.

14) Subjects taking monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit or with an anticipated need for MAOIs during the study.

15) Subjects with uncontrolled infection.

16) Subjects who have received treatment with an investigational drug (other than those in Studies CP043/06/FCNS and CP044/06/FCNS) within 4 weeks of the screening visit.

17) Subjects whose primary source of breakthrough pain is not cancer related.

Links

Registration Number: NCT00458510
Study Information on Clinical Trials Registry (clinicaltrials.gov)