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

Not Applicable

• Conditions: -D48 Neoplasm of uncertain or unknown behaviour of other and unspecified sites; Neoplasm of uncertain or unknown behaviour of other and unspecified sites; D48

• Registration Number: PER-003-14
• Lead Sponsor: GRUNENTHAL GmbH,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-27
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified