Pharmacokinetic, Safety, and Efficacy Study of SPARCs Paclitaxel Injection Concentrate for Nano-Dispersion (PICN) in subjects with Solid Tumors and With or Without Hepatic Impairment.

A Phase 1, Open Label, Dose-Ranging Pharmacokinetic, Safety, and Efficacy Study of Paclitaxel Injection Concentrate for Nano-Dispersion (PICN) Administered Every Three Weeks In Subjects with Solid Tumors and With or Without Hepatic Impairment.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037602

Enrollment

Registered

2021-10-27

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

Health Condition 1: null- Solid tumors and with or without hepatic impairment

Interventions

Intervention1: Paclitaxel Injection Concentrate for Nano- Dispersion (PICN): PICN will be infused intravenously (IV) every 3 weeks until evidence of disease progression, occurrence of unacceptable tox

Eligibility

Inclusion criteria

Inclusion criteria: 1. The subject has given written, informed consent and is available for the entire study; 2. Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage for which taxane-based therapy is a rational treatment option; 3. Documented normal hepatic function or hepatic impairment of: bilirubin > upper limit of normal (ULN) to ULN to ULN to ULN to 4. Age 18 to 65 years, inclusive; 5. ECOG Performance Status 6. Estimated life expectancy of at least 12-weeks; 7. Measurable disease according to RECIST v1.1 guideline;

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to both the study drugs or their excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol); 2. Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy; 3. Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0); 4. Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;

Design outcomes

Primary

Measure	Time frame
- Objective Response Rate - Pharmacokinetics (Cmax,AUC0-t, AUC0-infinity, MRT, Tmax, Kel, Vd - SafetyTimepoint: - Objective Response Rate - Baseline and on day 1 of alternate cycle 3, 5 ,7 etc. - Pharmacokinetics - pre-dose, up to 72.5 hrs after start of infusion of cycle 1.	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr Shravanti Bhowmik

Sun Pharma Advanced Research Company Ltd.

shravanti.bhowmik@sparcmail.com912266455626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026