Testimonials

It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China

Blog

Blog

Home / Blog

Advancing Pediatric Clinical Trials: Overcoming Challenges in the Clinical Trial of Pegfilgrastim for Rhabdomyosarcoma and Wilms' Tumor

09 Oct 2023

Overcoming Challenges in the Clinical Trial of Pegfilgrastim for Rhabdomyosarcoma and Wilms' Tumor

Study Overview:

Pegfilgrastim, a drug with proven efficacy in adults, was investigated in pediatric patients. Although studies in adults demonstrated similar efficacy to filgrastim, limited data existed for the pediatric population, specifically in rhabdomyosarcoma and Wilms' tumor patients.

Study Design:

A randomized active-controlled multi-center open-label two-arm study was designed to assess the safety, efficacy, pharmacodynamics, and pharmacokinetics of Pegfilgrastim PFS in comparison to the Reference Product in pediatric participants under 6 years old with rhabdomyosarcoma or Wilms' tumor.

Challenges and Solutions:

Challenges Solutions
Recruitment of Pediatric Patients:
  • Difficulty in identifying and recruiting pediatric patients (0 to 6 years old) with rhabdomyosarcoma or high-risk Wilms' tumor which are rare indications in pediatric oncology.
  • Requirement for patients on specific chemotherapy ranges, limiting the pool of eligible participants
  • Patient retention for 90 days
  • Identified investigator sites with substantial patient pools and extensive clinical trial experience, including government sites to enhance recruitment efforts.
Dosing and IMP Management:
  • Dosing calculation complexity due to the pediatric population and the need to finalize doses based on weight, resulting in very small IMP doses compared to the market-available doses.
  • Close oversight of IMP dosing, providing specialized dose calculation tables and 1 ml Tuberculin syringes to enhance dosing accuracy for the pediatric population.
  • A dedicated, trained, and experienced team of Phlebotomists was deployed
Handling of PK & PD Samples:
  • Sensitivity in handling PK & PD samples in the pediatric population, with the risk of mishandling leading to the loss of samples.
  • Conducted comprehensive training and continuous guidance for the site staff regarding dosing procedures, PK samples handling, and other critical aspects of the study.

Achievements:

  • Successfully randomized 12 pediatric patients within an impressive 7-month period, showcasing effective patient enrollment strategies.
  • Executed the trial efficiently within a timeline of 12 months, from the first site initiation visit (SIV) to the last patient's last visit, meeting the study's objectives and timelines for EMEA submission compliance.

Leverage Lambda & Novum's extensive experience & proven track record to accelerate your Pediatrics clinical trials. Get in touch with our team of experts.





Looking for a Globally Proven Research Partner?

Contact Us