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Trial record 1 of 1 for:    NCT00751205
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Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)

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ClinicalTrials.gov Identifier: NCT00751205
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Ovarian Cancer 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 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : August 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid
Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. In addition, subjects will receive Acetyl-L-Carnitine (ALC) 1000 mg tid. Treatment with Sagopilone and ALC will be continued as long as there is benefit. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.
Placebo Comparator: Arm 2 Drug: Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid
Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment will be continued as long as there is benefit. In addition, subjects will receive 21 weeks of placebo 1000 mg tid. After all patients have completed 6 cycles of treatment, an analysis will be performed to see whether ALC was better than placebo. If this is the case, patients still under placebo treatment will be offered to switch to ALC. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%)

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751205


Locations
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Belgium
Bruxelles - Brussel, Belgium, 1200
France
Caen, France, 14076
Montpellier Cedex, France, 34298
Nantes, France, 44805
Paris, France, 75012
Villejuif, France, 94805
Germany
Tübingen, Baden-Württemberg, Germany, 72076
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Bonn, Nordrhein-Westfalen, Germany, 53105
Essen, Nordrhein-Westfalen, Germany, 45122
Essen, Nordrhein-Westfalen, Germany, 45147
Magdeburg, Sachsen-Anhalt, Germany, 38108
Italy
Meldola, Forlì, Italy, 47014
Bologna, Italy, 40138
Rimini, Italy, 47900
Roma, Italy, 00189
Netherlands
Amsterdam, Netherlands, 1066 CX
Amsterdam, Netherlands, 1081 HV
Leiden, Netherlands, 2333 ZA
Maastricht, Netherlands, 6229 HX
United Kingdom
Leicester, Leicestershire, United Kingdom, LE1 5WW
Northwood, Middlesex, United Kingdom, HA6 2RN
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00751205    
Other Study ID Numbers: 91695
2008-000879-26 ( EudraCT Number )
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Peripheral Neuropathy
Prostate Carcinoma
Ovarian Carcinoma
Additional relevant MeSH terms:
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Acetylcarnitine
Prednisone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Sagopilone
Epothilones
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nootropic Agents
Tubulin Modulators
Antimitotic Agents