Colorectal NeoplasmsPhase 3XENONNCT00603577
Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens
A Phase 3 study testing Xaliproden in people with Colorectal Neoplasms, run by Sanofi at 8 sites in 8 countries.
Trial summary
Primary objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Xaliproden
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jan 2008to Nov 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
- Have Grade ≥ 1 PSN, as defined by the NCI-CTCAE version 3.0
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
- Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 x upper limit of normal (ULN); (b) serum creatinine ≤1.5 x ULN; (c)HbA1c ≤7%; (d) neutrophils ≥1.5x10^9/L ; (e) platelets ≥50x10^9/L; (f) Serum D-dimer within normal limits
Who cannot join
- Pre-existing peripheral neuropathy prior to treatment with oxaliplatin
- Receiving any further anti-cancer treatment
- History of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
- Unstable cardiac disease
- History of significant neurological or psychiatric disorders including dementia or seizures,
- Active uncontrolled infection
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- Active disseminated intravascular coagulation
- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
- Use of antidepressant/antiepileptic medication (for the treatment of PSN), unless commenced before informed consent form signed. The addition of these medications (for the treatment of PSN) once the patient has consented is not allowed
- Concurrent treatment with any other experimental drugs
- Pregnant or breast-feeding women;
- Women of childbearing potential must be protected by effective contraceptive methods of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be assessed with the patient before registration in the trial.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer
Primary objective:
To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.
Read more
Secondary objective:
- To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
- To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months
- To assess the effects of xaliproden on the time to complete recovery from PSN
- To evaluate the safety profile of xaliproden
- Conditions
- Colorectal Neoplasms
- Being tested
- Placebo, Xaliproden
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
XaliprodenDrug
1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Xaliproden | Experimental | Not described Receives: Drug: Xaliproden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0)
Measured: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits
Secondary outcomes (3)
FACT/GOG NTX-12 subscale
Measured: AT inclusion and subsequently monthly until month 12
Hematological and biochemical testing
Measured: At inclusion, 3 & 6 months
AE graded with NCI-CTCAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1)
Measured: During the whole study period (including follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: development of product discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Aussel, Principal investigator, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603577
- Sponsor's protocol ID
- XALIP_C_02090
- Acronym
- XENON
- Status last verified
- Apr 2016
- First submitted
- 17 Jan 2008
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer
- ClinicalTrials.gov ID
- NCT00603577
- Acronym / sponsor ID
- XENON / XALIP_C_02090
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: development of product discontinued
- Enrolment
- 102 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Jan 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.
Primary objective:
To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.
Secondary objective:
- To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
- To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months
- To assess the effects of xaliproden on the time to complete recovery from PSN
- To evaluate the safety profile of xaliproden
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Xaliproden | Experimental | Drug: Xaliproden |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
- Have Grade ≥ 1 PSN, as defined by the NCI-CTCAE version 3.0
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
- Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 x upper limit of normal (ULN); (b) serum creatinine ≤1.5 x ULN; (c)HbA1c ≤7%; (d) neutrophils ≥1.5x10^9/L ; (e) platelets ≥50x10^9/L; (f) Serum D-dimer within normal limits
Key exclusion criteria (14 listed)
- Pre-existing peripheral neuropathy prior to treatment with oxaliplatin
- Receiving any further anti-cancer treatment
- History of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
- Unstable cardiac disease
- History of significant neurological or psychiatric disorders including dementia or seizures,
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 |
|---|---|---|
| PlaceboXaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first). | Drug | Placebo |
| Xaliproden1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first). | Drug | Xaliproden |
Primary outcome
Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0)
Time frame: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits
3 secondary outcomes
FACT/GOG NTX-12 subscale
Time frame: AT inclusion and subsequently monthly until month 12
Hematological and biochemical testing
Time frame: At inclusion, 3 & 6 months
AE graded with NCI-CTCAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1)
Time frame: During the whole study period (including follow-up)
Results and safety
The study was stopped early (reason given: development of product discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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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.
Jean-Philippe Aussel principal investigator
Sanofi
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xaliproden in people with Colorectal Neoplasms, run by Sanofi at 8 sites in 8 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, France, Germany, Greece and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: development of product discontinued). Results are not available in the source record.
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?
Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0) (time frame: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2016.