A clinical trial to study the effects of Nanoparticle based Paclitaxel drug, which does not contain the solvent cremophor, in advanced breast cancer

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000219

Enrollment

Registered

2009-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nanoxel (Nanoparticle Paclitaxel): 4 different dose levels of 220, 260, 310 and 375 mg/m2 Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: i. Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent to previous anthracycline treatment as adjuvant or first line therapy for metastasis. ii. Patients with ER/PR ?ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status) iii. Patients must be of 18-65 years of age iv. Patients with ECOG performance status between 0 ? 2 v. Patients with at least one measurable lesion as per RECIST

Exclusion criteria

Exclusion criteria: i. Patients with ER/PR positive status. Patients who demonstrate HER2 over expression will be excluded. Alternatively, the patients enrolled should have previously received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+ or with FISH/CIS. ii. Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients. iii. Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. iv. Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).

Design outcomes

Primary

Measure	Time frame
To generate the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2)and to determine the maximum tolerated dose (MTD) of Nanoxel ; Evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc (Safety evaluation)Timepoint: Dose Limiting Toxicity (DLT) occuring at the mentioned levels of Nanoxel infusion will define the MTD. Safety evaluation by recording ECG's at various timepoints during and post infusion.	—

Measure

Time frame

To generate the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2)and to determine the maximum tolerated dose (MTD) of Nanoxel ; Evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc (Safety evaluation)Timepoint: Dose Limiting Toxicity (DLT) occuring at the mentioned levels of Nanoxel infusion will define the MTD. Safety evaluation by recording ECG's at various timepoints during and post infusion.

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr S K Mishra

shivakant.mishra@fresenius-kabi.com0124-4884146

Outcome results