NCT00915369

A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer

Status unknown Phase 1 Last updated 5 February 2010

What this trial tests

Phase 1 trial testing Nanoxel (Paclitaxel Nanoparticle formulation ) in Advanced Breast Cancer in 24 participants. Status unknown.

Timeline

1 March 2009

Primary endpoint
1 April 2010

1 April 2010

Quick facts

Lead sponsor	Fresenius Kabi Oncology Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 March 2009
Primary completion	1 April 2010
Estimated completion	1 April 2010
Sites	3 locations across India

Drugs / interventions tested

• Nanoxel (Paclitaxel Nanoparticle formulation ) — full drug profile →

Conditions studied

• Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

Fresenius Kabi Oncology Ltd. — full company profile →

Who can join

Adults 18 to 65, female only, with Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary outcomes of the study would be the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2); Ability to identify a dose higher than 220 mg/m2 that demonstrate better efficacy and manageable toxicity
  Time frame: Throughout the study

Sponsor's own description

This study is a multicentre, open label, non-randomized phase I study. The main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Polymeric Nanoparticles for Drug Delivery.
   Beach MA, Nayanathara U, Gao Y, Zhang C, et al · · 2024 · cited 476× · PMID 38626459 · DOI 10.1021/acs.chemrev.3c00705
2. Cancer nanomedicine: a review of nano-therapeutics and challenges ahead.
   Nirmala MJ, Kizhuveetil U, Johnson A, G B, et al · · 2023 · cited 86× · PMID 36926304 · DOI 10.1039/d2ra07863e
3. Polymeric Micellar Systems-A Special Emphasis on "Smart" Drug Delivery.
   Negut I, Bita B. · · 2023 · cited 66× · PMID 36986837 · DOI 10.3390/pharmaceutics15030976
4. Polymeric Micelles for Breast Cancer Therapy: Recent Updates, Clinical Translation and Regulatory Considerations.
   Junnuthula V, Kolimi P, Nyavanandi D, Sampathi S, et al · · 2022 · cited 52× · PMID 36145608 · DOI 10.3390/pharmaceutics14091860
5. Injectable Nano Drug Delivery Systems for the Treatment of Breast Cancer.
   Kafle U, Agrawal S, Dash AK. · · 2022 · cited 25× · PMID 36559276 · DOI 10.3390/pharmaceutics14122783
6. Functionalized Polymeric Micelles for Targeted Cancer Therapy: Steps from Conceptualization to Clinical Trials.
   Serras A, Faustino C, Pinheiro L. · · 2024 · cited 4× · PMID 39204392 · DOI 10.3390/pharmaceutics16081047
7. Comprehensive scientific insights on plant inspired nano therapeutics as the missing piece of the breast cancer puzzle.
   Bhattacharya J, Saifullah Q, Dutta K, Chakrabarty S, et al · · 2026 · PMID 42151631 · DOI 10.1186/s11671-026-04621-7
8. Advances in Polymer Micelles for Cancer Therapy: From Conventional to Smart Delivery Systems
   Bryaskova R, Staykov K, Ganchev D. · · 2026