Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003885

Trial Description

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Title

(REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the
safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced
peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours
on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient
is benefitting. In addition patients will receive ALC or placebo, starting 1 week before
first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone.
Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be
determined by the incidence of all grades of peripheral neuropathy with the results of a
patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined
by the tumor response.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003885
  •   2012/04/30
  •   2008/09/10
  •   no
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Secondary IDs

  •   2008-000879-26 
  •   NCT00751205  (ClinicalTrials.gov)
  •   91695  (Bayer)
  •   2008-000879-26 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   Ovarian Cancer
  •   C61 -  Malignant neoplasm of prostate
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Drug: Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid
  •   Drug: Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.; time frame: Start of Sagopilone treatment until at most 6 cycles + 1 month.

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Secondary Outcome

- Efficacy of ALC: incidence of neuropathy of grade 3 or 4, time to onset of neuropathy, duration of neuropathy.; time frame: Start of treatment to safety Follow-up
- Efficacy of ALC: Percentage of discontinuations due to neuropathy.; time frame: Start of treatment to safety Follow-up
- Safety of Sagopilone in combination with ALC.; time frame: Baseline to Safety follow-up
- Efficacy of Sagopilone: 'best overall response' according to modRECIST criteria; time frame: Start treatment to End of Treatment
- Efficacy of Sagopilone: 'best overall response' according to CA-125 or PSA response; time frame: Start treatment to End of Treatment
- Efficacy of Sagopilone: Time to disease progression, Progression-free survival; time frame: Start treatment to Progression or Death
- Efficacy of Sagopilone: Duration of response; time frame: Start treatment to Progression or Death
- Efficacy of Sagopilone: WHO performance status.; time frame: Screening to end of Treatment
- Pharmacokinetic: Sagopilone concentrations (optional); time frame: Day 1,2,3,5,15 of cycle 1 and day2
- Pharmacokinetic: ALC concentrations; time frame: radomisation, day 1 of cycle 1 and 2
- Pharmacogenomics (optional): in tumor tissue, blood and ascites; time frame: Blood sample at screening, tissue sample and ascites whenever available

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Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2008/08/31
  •   166
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- Males or females aged >/= 18 years

- Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or
clear cell tumors) or Adenocarcinoma of the prostate

- At least 1 unidimensional measurable lesion (suitable for RECIST evaluation) or for
patients without measurable disease, CA 125 levels >/= 2 times the upper limit of
normal (ULN) within 3 months and confirmed within 2 weeks prior to first infusion
(ovarian cancer) or PSA value >/= 5 ng/mL (HRPC).

- Progression of disease (HRPC) despite adequate androgen-inhibiting hormone therapy.

- Progression of disease (Ovarian Cancer) or symptomatic relapse after previous therapy
(elevated CA125 levels alone are insufficient for inclusion) WHO performance status 0
to 1

- No clinical residual neuropathy (CTCAE Grade 0 at baseline)

- Adequate recovery from previous surgery, radiation, and chemotherapy (excluding
alopecia)

- Adequate function of major organs and systems.

- Survival expectation =3 months

- Histologically or cytologically proven:

1. Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucionous
cell tumors or clear cell tumors that have a clear cell component of >33%)

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Exclusion Criteria

- Symptomatic brain metastases requiring whole- brain irradiation

- Any concomitant malignancy: the following exceptions are allowed: Non-melanoma skin
cancer, Carcinoma in situ of the cervix, Malignancy with definitive treatment >/= 5
years ago without relapse.

- Diabetes mellitus (even if controlled only by special diet)

- History of chronic hepatitis B or C, or known HIV infection

- Seizure disorder requiring medication (such as steroids or anti-epileptics)

- Inability to swallow oral medications

- Prior treatment with epothilones

- Concomitant use of neurotoxic drugs

- Concomitant use of compounds that have potentially positive effects towards symptoms
of neuropathy

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2010/08/01
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.