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Open-label, Single-arm, Flexible Dosing, Phase III Trial, With Oral Tapentadol PR in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial.

Phase 3
18 Years
Open (Enrolling)
Cancer, Chronic Pain, Pain, Tumour Related Pain

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Trial Information

Open-label, Single-arm, Flexible Dosing, Phase III Trial, With Oral Tapentadol PR in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial.

The prevalence of tumor-related pain is high and the treatment of chronic tumor-related pain
remains a challenging therapeutic problem.

This is a clinical trial with only 1 treatment group: tapentadol ER 100 mg to 250 mg twice

For subjects who have directly entered the KF5503/52 trial from the KF5503/15 trial (i.e.,
within 7 days of Visit 8 of the KF5503/15 trial): a Transfer Visit, an Open-label Treatment
Period and a Follow-up Period.

For subjects who have a gap of more than 7 days and less than 24 weeks, between their full
completion of the KF5503/15 trial and entry into the KF5503/52 trial: an Enrollment Visit,
an Entry Visit for assessment of eligibility, an Open-label Treatment Period and a Follow-up

This trial was designed to offer patients with chronic malignant tumor-related pain the
option of continuing treatment by receiving tapentadol PR.

Inclusion Criteria:

- Subjects must have signed an Informed Consent Form.

- At least 18 years of age.

- Male and non-pregnant, non-lactating female subjects. Sexually active women must be
post menopausal, surgically sterile, or practicing an effective method of birth
control before entry and throughout the trial. Female subjects of child-bearing
potential must have a negative pregnancy test at enrollment.

- Within 24 weeks of either full completion or completion of the Double-blind Treatment
Period (Visit 8) of KF5503/15 trial performed in subjects with moderate to severe
chronic malignant tumor related pain.

- Subject is, in the opinion of the Investigator, expected to continue to have an
overall positive benefit/risk ratio from continuing analgesic treatment within this

- Subjects must be willing to take tapentadol PR throughout their participation in the

Exclusion Criteria:

- History of alcohol and/or drug abuse.

- The subject has a clinically significant disease other than cancer that in the
Investigator's opinion may affect the safety of the subject.

- Employees of the Investigator or trial center or family members of the employees or
the Investigator.

- Known to or suspected of not being able to comply with the protocol and the use of
tapentadol PR.

- Concurrent participation in another trial (except for participation in the KF5503/15
trial) or planning to be enrolled in another clinical trial during the course of this

- Previous participation in another trial between the end of KF5503/15 and enrollment
into the current trial, KF5503/52.

- History of seizure disorder, epilepsy, traumatic brain injury, stroke or transient
ischemic attack.

- Known history and/or presence of cerebral tumors or metastases.

- Rapidly escalating pain or pain uncontrolled by therapy and was previously treated
with maximum (dose level 4) Investigational Medicinal Product dose.

- Subjects taking any prohibited concomitant medications.

- Uncontrolled hypertension.

- Known moderate or severe hepatic impairment.

- Known severe renal impairment.

- Clinically relevant history of hypersensitivity, allergy, or contraindications to
mu-opioid receptor agonists.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of subjects with Adverse Events as a measure of safety and tolerability

Outcome Time Frame:

From date of first IMP intake until date of 3 days after last IMP intake, assessed up to 4 years

Safety Issue:


Principal Investigator

Hans-Georg Kress, Prof. Dr. med

Investigator Role:

Principal Investigator

Investigator Affiliation:

General Hospital Vienna


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

December 2010

Completion Date:

April 2015

Related Keywords:

  • Cancer
  • Chronic Pain
  • Pain
  • Tumour Related Pain
  • analgesia
  • analgesics
  • cancer
  • chronic pain
  • pain
  • tumour related pain
  • Neoplasms