Prostate CancerPhase 2NCT00751205
Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)
A Phase 2 study testing Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid in people with Prostate Cancer and Ovarian Cancer, run by Bayer at 22 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prostate Cancer, Ovarian Cancer
- What is being tested?
- Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 22 sitesin 6 countries
- Study dates
- Aug 2008to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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:
- Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucionous cell tumors or clear cell tumors that have a clear cell component of >33%)
Who cannot join
- 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
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- Prior treatment with epothilones
- Concomitant use of neurotoxic drugs
- Concomitant use of compounds that have potentially positive effects towards symptoms of neuropathy
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
Germany6 sites
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Essen, North Rhine-Westphalia, 45122
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Magdeburg, Saxony-Anhalt, 38108
Study site
Rostock, Mecklenburg-Vorpommern, 18059
Study site
Tübingen, Baden-Wurttemberg, 72076
France5 sites
Study site
Caen, 14076
Study site
Montpellier, 34298
Study site
Nantes, 44805
Study site
Paris, 75012
Study site
Villejuif, 94805
Italy4 sites
Study site
Bologna, 40138
Study site
Meldola, Forlì, 47014
Study site
Rimini, 47900
Study site
Roma, 00189
Netherlands4 sites
Study site
Amsterdam, 1066 CX
Study site
Amsterdam, 1081 HV
Study site
Leiden, 2333 ZA
Study site
Maastricht, 6229 HX
United Kingdom2 sites
Study site
Leicester, Leicestershire, LE1 5WW
Study site
Northwood, Middlesex, HA6 2RN
About this study
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.
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.
- Conditions
- Prostate Cancer, Ovarian Cancer
- Being tested
- Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid, Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid
- Keywords
- Peripheral Neuropathy, Prostate Carcinoma, Ovarian Carcinoma
- Medical subject headings
- Prostatic Neoplasms, Ovarian Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bidDrug
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.
Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.
Measured: Start of Sagopilone treatment until at most 6 cycles + 1 month.
Secondary outcomes (11)
Efficacy of ALC: incidence of neuropathy of grade 3 or 4, time to onset of neuropathy, duration of neuropathy.
Measured: Start of treatment to safety Follow-up
Efficacy of ALC: Percentage of discontinuations due to neuropathy.
Measured: Start of treatment to safety Follow-up
Safety of Sagopilone in combination with ALC.
Measured: Baseline to Safety follow-up
Efficacy of Sagopilone: 'best overall response' according to modRECIST criteria
Measured: Start treatment to End of Treatment
Efficacy of Sagopilone: 'best overall response' according to CA-125 or PSA response
Measured: Start treatment to End of Treatment
Efficacy of Sagopilone: Time to disease progression, Progression-free survival
Measured: Start treatment to Progression or Death
Efficacy of Sagopilone: Duration of response
Measured: Start treatment to Progression or Death
Efficacy of Sagopilone: WHO performance status.
Measured: Screening to end of Treatment
Pharmacokinetic: Sagopilone concentrations (optional)
Measured: Day 1,2,3,5,15 of cycle 1 and day2
Pharmacokinetic: ALC concentrations
Measured: radomisation, day 1 of cycle 1 and 2
Pharmacogenomics (optional): in tumor tissue, blood and ascites
Measured: Blood sample at screening, tissue sample and ascites whenever available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751205
- Sponsor's protocol ID
- 91695
- Other IDs
- 2008-000879-26, 2008
- Status last verified
- Oct 2014
- First submitted
- 10 Sep 2008
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Campone M, Berton-Rigaud D, Joly-Lobbedez F, Baurain JF, Rolland F, Stenzl A, Fabbro M, van Dijk M, Pinkert J, Schmelter T, de Bont N, Pautier P. A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.
PubMed 24105751
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00751205
- Acronym / sponsor ID
- 91695
- Conditions
- Prostate Cancer, Ovarian Cancer
- Keywords
- Peripheral Neuropathy, Prostate Carcinoma, Ovarian Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid |
| Arm 2 | Placebo comparator | Drug: Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bidSubjects 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. | Drug | Arm 1 |
| Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bidSubjects 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. | Drug | Arm 2 |
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.
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Derived from this study: PubMed 24105751Campone M, Berton-Rigaud D, Joly-Lobbedez F, Baurain JF, Rolland F, Stenzl A, Fabbro M, van Dijk M, Pinkert J, Schmelter T, de Bont N, Pautier P. A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid in people with Prostate Cancer and Ovarian Cancer, run by Bayer at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, France, Italy, Netherlands, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00751205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.