Effect of TRO19622 in the Treatment of Patients With Chemotherapy Induced Peripheral Neuropathy

NCT00876538 | Completed Phase 2

• 3 other identifiers: WN29851EudraCT number: 2008-001218-26TRO19622 CL E Q 1204-1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Keywords

Chemotherapy Induced Peripheral Neuropathy; TR019622; Trophos

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the measure of the percentage of responders defined as patients with a minimum decrease of 50 % of their maximum neuropathic pain dimension (either pain or dysesthesia) present at baseline.

  The mean pain score during the last 7 days of the treatment period will be compared to the mean score of the last 7 days of the screening score period.

Secondary Outcomes (11)

• Assessment with respect to placebo of the effect of TRO19622 on Neuropathic Pain Inventory Score(total and by dimension)

  Screening visit; V0; V1; V2; V3; V4 ; V5

• Assessment with respect to placebo of the effect of TRO19622 on Short- Form BPI

  Screening visit; V0; V1; V2; V3; V4 ; V5

• Assessment with respect to placebo of the effect of TRO19622 on Quality of life questionnaire (CIPN 20)

  V0; V3; V5

• Assessment with respect to placebo of the effect of TRO19622 on Dysgueusia questionnaire

  V0; V3; V5

• Assessment with respect to placebo of the effect of TRO19622 on Quantitative Sensory Testing

  V0; V3; V5

Study Arms (2)

TRO19622

EXPERIMENTAL

2 capsules of TRO19622 (330mg) once day with the noon meal

Drug: Olesoxime (TRO19622)

Control

PLACEBO COMPARATOR

2 capsules of placebo once day with the noon meal

Drug: Placebo Control

Interventions

Olesoxime (TRO19622) DRUG

2 capsules of TRO19622 (330 mg) once day with the noon meal

TRO19622

Placebo Control DRUG

Placebo Control 2 capsules once day with the noon meal

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed an Informed Consent to participate to the trial before any study related procedure has taken place.
• Be \>18 years and if a female with adequate contraception if of child bearing potential.
• Have paclitaxel (or other taxane) induced peripheral neuropathy assessed by the presence of a NCI-CTC version 2 neuropathy sensory grade \>/= 2 .
• Peripheral neuropathy as clinically diagnosed during the neurological examination including sensitivity, motor function and deep tendon reflex assessments
• With Neuropathic pain as assessed by the presence of measurable pain perception (previous 24h)on the Likert numerical rating scale \>/= 4 points at the screening visit and confirmed on DN4 with a score \>/= 4 and/or Dysesthesia as assessed by the presence of measurable dysesthesia (previous 24h) on the Likert numerical rating scale \>/= 4 points at the screening visit
• Persistent neuropathy for at least 3, but no more than 12 months after the end of chemotherapy.
• Be either pain treatment naive or have important side effects or inadequate relief from their current pain medication (stable over last month).
• Peripheral neuropathy symptoms: Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean \>/= 4 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit and/or Dysesthesia as assessed by the presence of measurable dysesthesia with a mean \>/= 4 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit.
• Have an electrocardiogram (ECG) at Baseline without any clinically significant abnormality.
• Have an expected survival \> 6 months.

You may not qualify if:

• Have a documented neuropathy or risk factors of neuropathy which might interfere with the assessment of the severity of pain (eg, including, but not limited to, type 2 diabetes, peripheral vascular disease, B12 Vitamin deficiency, thyroid dysfunction, post surgical neuropathic pain, post-traumatic neuropathy, or neuropathy in relation with disease progression).
• Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
• Refractory to treatment defined as not improved, according to the Investigator, by 3 or more treatments prescribed for the current PN symptoms.
• HIV positive serology.
• History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease,including myocardial infarction, except patients with only well controlled hypertension.
• Have had prior (within the past 6 months) or have concurrent neurotoxic drugs (e.g., but not limited to, cisplatin, vincristine, vinblastine, cytarabine, thalidomide, bortezomib, or procarbazine, capecitabine, navelbine).
• Have a current medication that may have a similar mechanism of action as TRO19622: acetyl-L-carnitine
• Have a current medication that could interfere with TRO19622 pharmacokinetics: tamoxifen
• Have current medications that could interfere with TRO19622 absorption such as ezetimibe, bile salts chelators, fibrates, phytosterols, fish oils.
• Have a current medication of lipid lowering agents other than statins.
• Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
• Have concurrent unstable disease involving any system (eg, advanced carcinoma other than carcinoma justifying the recent treatment with taxanes, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, anginal symptoms, current symptoms of CAD, renal impairment, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation)
• Be pregnant female or lactating.
• Have renal impairment defined as blood creatinine \> 1.5× upper limit of normal (ULN)
• Hemostasis disorders or current treatment with oral anticoagulants.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Centre Hospitalier de Versailles Hôpital André Mignot Service d'Hématologie-Oncologie

Le Chesnay, 78157, France

Location

Centre Oscar Lambret Département de Sénologie

Lille, 59000, France

Location

Centre Léon Bérard Département de Soins de Support

Lyon, 69373, France

Location

C.R.L.C Val d'Aurelle Service d'Oncologie Médicale

Montpellier, 34298, France

Location

Centre Alexis Vautrin

Nancy, 54511, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hôpital Nord CHU Saint Etienne Centre de la douleur

Saint-Etienne, 42055, France

Location

Hôpital Privé de l'Ouest Parisien Service d'Oncologie

Trappes, 78190, France

Location

MeSH Terms

Interventions

olesoxime

Study Officials

• Ivan Krakowski, MD

  Centre Alexis Vautrin / Département d'Oncologie Médicale/ Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

FR (8)