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Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

N

NeoTherapeutics

Status and phase

Completed
Phase 2

Conditions

Peripheral Nervous System Diseases
Chemotherapy-Induced Peripheral Neuropathy

Treatments

Drug: leteprinim potassium (Neotrofin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00041795
082-2001-005

Details and patient eligibility

About

This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Patient must have diagnosis of cancer and be receiving or have received chemotherapy that has resulted in sensory or motor neuropathy.
  • Sensory or motor neuropathy must be >/= grade 2 per Common Toxicity Criteria at baseline.
  • In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is acceptable.
  • Patient must have normal hematological cell counts.
  • Patient must have a life expectancy of >/= 3 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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