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(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.


Phase 2
18 Years
70 Years
Not Enrolling
Both
Prostate Cancer, Ovarian Cancer

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Trial Information

(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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.

Outcome Time Frame:

Start of Sagopilone treatment until at most 6 cycles + 1 month.

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

91695

NCT ID:

NCT00751205

Start Date:

August 2008

Completion Date:

August 2010

Related Keywords:

  • Prostate Cancer
  • Ovarian Cancer
  • Peripheral Neuropathy
  • Prostate Carcinoma
  • Ovarian Carcinoma
  • Ovarian Neoplasms
  • Peripheral Nervous System Diseases
  • Prostatic Neoplasms

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