Phase 3 Peripheral Neuropathy Trial, Recruiting NCT06994507 Sponsor: Qilu Pharmaceutical Co., Ltd. Condition: Peripheral Neuropathy
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Phase 3 Peripheral Neuropathy Trial, Recruiting

NCT06994507
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing to voluntarily sign a consent form agreeing to take part in the study
  • People aged between 18 and 75 years old
  • Women diagnosed with breast cancer (confirmed through tissue or cell testing) who are planned to receive a chemotherapy treatment called albumin paclitaxel as part of their cancer treatment, either before or after surgery
  • People whose general health and ability to carry out daily activities meets a standard score of 0 or 1 on a common medical scale (confirm with trial site)
  • People whose liver, kidneys, and other organs are functioning well enough to meet the trial's requirements
  • People whose blood sugar control is within a certain range, specifically a blood test result called HbA1c (a measure of average blood sugar over time) must be below 7.0%
  • Women who could become pregnant must agree to use effective contraception from the time they sign the consent form until 30 days after their last dose of the study drug
  • People who are able to fill in questionnaires accurately to describe any nerve-related symptoms they experience, such as tingling or numbness

Who may not be able to join:

  • People who already have any degree of nerve damage or numbness (called peripheral neuropathy), even mild, as measured by standard medical rating tools
  • People who have other existing risk factors that could cause nerve damage, not related to chemotherapy
  • People who have had a history of a different type of cancer (other than breast cancer)
  • People who have muscle pain or similar symptoms in their limbs that could make it difficult to accurately assess nerve damage during the trial
  • People with heart, blood vessel, or brain circulation problems that are not well controlled, or high blood pressure that is not well managed
  • People who have had an active infection requiring treatment — such as a bacterial, fungal, or viral infection — within the week before starting the study drug, or who had infectious diarrhoea within the four weeks before starting the study drug
  • People with inherited conditions affecting how the body processes fats and sugars, HIV infection or AIDS, a positive syphilis antibody test, active hepatitis B, or active hepatitis C

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 010-66947175

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Qilu Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
1 September 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

FACT/GOG-Ntx scores with a change of more than 12 points from the baseline

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov