Nanosomal Docetaxel for Triple Negative Breast Cancer

Recruiting at 3 trial locations

Overseen By Mr. Prashant Modi

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Jina Pharmaceuticals Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new, safer form of the cancer drug docetaxel, called Nanosomal Docetaxel Lipid Suspension (NDLS), in patients with advanced or spreading triple-negative breast cancer. NDLS aims to reduce side effects by using tiny fat particles. The drug works by stopping cancer cells from dividing and growing. Docetaxel is a widely used chemotherapy drug, and newer formulations like Nanosomal Docetaxel Lipid Suspension (NDLS) aim to improve its efficacy and reduce toxicity.

Research Team

Dr. Ravi Alamchandani

Principal Investigator

Lambda Therapeutic Research Ltd.

Eligibility Criteria

This trial is for patients with triple-negative breast cancer who have had one prior chemotherapy regimen and are not currently pregnant or breastfeeding. They must have a measurable lesion, an ECOG status of 0-2, normal heart function, and adequate organ function. Exclusions include hypersensitivity to Docetaxel, HER2 positive or hormone receptor-positive cancers, uncontrolled diabetes/infection, recent participation in another drug study, known brain metastases (unless asymptomatic), significant neuropathy or cardiac issues.

Inclusion Criteria

My breast cancer is advanced and previous chemotherapy didn't work.

I have recovered from side effects of my previous cancer treatments.

Patients with life expectancy of at least 6 months.

Exclusion Criteria

I am willing and able to follow the study's requirements.

I do not have uncontrolled diabetes or infections.

You have had a drug addiction in the past year.

Treatment Details

Interventions

• Nanosomal Docetaxel Lipid Suspension (Anti-mitotic Agent)

Trial Overview The trial tests Nanosomal Docetaxel Lipid Suspension at two doses (75 mg/m2 and 100 mg/m2) against the standard Taxotere® at 100 mg/m2 in patients with advanced breast cancer. It aims to improve safety by eliminating certain excipients found in conventional formulations. The efficacy will be measured using RECIST guidelines across three groups of participants.

Participant Groups

Group I: T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2) Experimental Treatment 1 Intervention

Experimental: NDLS for Injection, 100 mg/ m2 Nanosomal Docetaxel Lipid Suspension for Injection; Dose: 100 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity

Group II: Nanosomal Docetaxel Lipid Suspension - 75 mg/m2 Experimental Treatment 1 Intervention

Experimental: NDLS for Injection, 75 mg/ m2 Nanosomal Docetaxel Lipid Suspension for Injection; Dose: 75 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity

Group III: R, Taxotere® (100 mg/m2) Active Control 1 Intervention

Active Comparator: Taxotere® Injection Concentrate Docetaxel Injection Concentrate; Dose: 100 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity

Who Is Running the Clinical Trial?

Jina Pharmaceuticals Inc.

Lead Sponsor

Trials

7

Recruited

1,700+

Intas Pharmaceuticals, Ltd.

Industry Sponsor

Trials

4

Recruited

1,100+

Lambda Therapeutic Research Ltd.

Industry Sponsor

Trials

8

Recruited

1,900+