CORAL XT – OPEN-LABEL EXTENSION TRIAL OF THE CORAL TRIAL

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-003-14
• Date of registration: 27/06/2014
• Prospective Registration: No
• Primary sponsor: GRUNENTHAL GmbH,
• Public title: CORAL XT – OPEN-LABEL EXTENSION TRIAL OF THE CORAL TRIAL
• Scientific title: AN OPEN-LABEL, MULTI-SITE TRIAL TO DESCRIBE THE SAFETY AND TOLERABILITY OF ORAL CEBRANOPADOL ADMINISTERED FOR 26 WEEKS IN SUBJECTS WITH CANCER-RELATED PAIN WHO HAVE COMPLETED TREATMENT IN THE KF6005/07 TRIAL.
• Date of first enrolment: 31/01/2014
• Target sample size: 22
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=003-14
• Study type: Interventional
• Study design: This is a non-randomized, multi-site, open-label, single-arm Phase III trial to describe the safety and; tolerability of oral cebranopadol for 26-weeks in subjects with cancer-related pain who have completed treatment in the KF6005/07 trial
• Phase: III

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, Denmark, France, Germany, Hungary, Mexico, New Zealand, Peru, Poland, Romania, Serbia, Slovakia, Spain, Sweden, United Kindgdom

Contacts

• Name: Rosario Chang Torres
• Affiliation: GRUNENTHAL PERUANA S.A.

• Name: Rosario Chang Torres
• Affiliation: GRUNENTHAL PERUANA S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Informed consent signed indicating that the subject understands the purpose of and procedures required for the trial and is willing to participate in the trial.
2. Subjects must be at least 18 years of age at the Enrollment Visit
3. Women of childbearing potential must have a negative pregnancy test at Visit 1 and must not be lactating at Visit 1.
4. Subjects must be willing to use medically acceptable and highly effective methods of birth control. For women of childbearing potential a medically acceptable and highly effective method of birth control is defined as any form of contraception with a low failure rate defined as <1% per year. For example:
• Hormonal contraceptives for the duration of the trial and until for at least 4 weeks after Final Visit.
• An intra-uterine device.
Additional barrier contraception must be used by the partner for the duration of the trial. A double-barrier method should be supplemented by the use of spermicidal agents. Women of nonchildbearing potential may be included if surgically sterile (i.e., after hysterectomy) or post-menopausal for at least 2 years and ≥55 years old.
For men:

Exclusion criteria:
1. The subject has a clinically significant disease or condition other than cancer which in the investigator´s opinion may affect efficacy or safety assessments, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric
(resulting in disorientation, memory impairment or inability to report accurately) or metabolic disorders or clinically relevant history of hypersensitivity, allergy or contraindications to opioid medication or any of the excipients of cebranopadol film-coated tablets.
2. Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
3. Subjects taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment (see Section 10.5).
4. History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia).
5. Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial.


Age minimum: 18
Age maximum: 99
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasm of uncertain or unknown behaviour of other and unspecified sites

-D48 Neoplasm of uncertain or unknown behaviour of other and unspecified sites
Neoplasm of uncertain or unknown behaviour of other and unspecified sites

D48

Intervention(s)

Subjects will receive cebranopadol and the dose will be up- or down-titrated to reach the individual subjects’ optimal dose defined as a balance between self-reported analgesia and side effects during the approximately 2-week Titration Phase. The Titration Phase will be followed by 24 weeks of Maintenance Phase. During the Maintenance Phase, subjects will be advised to continue their treatment at the dose which was selected during the Titration Phase. However, the dose of cebranopadol can be adjusted at any time as required (based on self-reported analgesia and adverse events [AEs]) during a scheduled or unscheduled visit at the site or after contacting the site by phone. Cebranopadol film-coated tablets will be taken once daily. The available dose strengths are 200 μg, 400 μg, and 600 μg. The minimum daily dose will be cebranopadol 200 μg per day; the maximum daily dose will be cebranopadol 1000 μg per day.

Source(s) of Monetary Support

GRUNENTHAL GmbH

Ethics review

Status: Approved
Approval date: 23/10/2013
Contact:

[e-mail]

HOSPITAL CENTRAL DE LA FUERZA AEREA DEL PERU

996139373

[e-mail]

Status: Approved
Approval date: 24/10/2013
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 14/11/2013
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 23/12/2013
Contact:

[e-mail]

Hospital Nacional Edgardo Rebagliati Martins

2654901-3080 2640516

[e-mail]

Status: Approved
Approval date: 23/01/2014
Contact:

[e-mail]

Hospital Nacional Dos de Mayo

3280028

[e-mail]

Status: Approved
Approval date: 11/03/2014
Contact:

[e-mail]

Instituto Nacional de Enfermedades Neoplasicas

7106099-3001

[e-mail]

Status: Approved
Approval date: 24/03/2014
Contact:

[e-mail]

Instituto Regional de Oftalmologia - Trujillo

044-249066

[e-mail]

Status: Approved
Approval date: 09/05/2014
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Status: Approved
Approval date: 04/07/2014
Contact:

[e-mail]

Hospital Nacional Almanzor Aguinaga Asenjo -EsSalud

237776 - 2319

[e-mail]