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

Phase 1

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

• Registration Number: CTRI/2021/10/037602
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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 <= 1.25 x ULN and AST > ULN to < 10 x ULN; bilirubin 1.26 to 2.0 x ULN and AST >

ULN to < 10 x ULN; and bilirubin 2.01 to 5.0 x ULN and AST > ULN to < 10 x ULN.

4. Age 18 to 65 years, inclusive;

5. ECOG Performance Status <= 2;

6. Estimated life expectancy of at least 12-weeks;

7. Measurable disease according to RECIST v1.1 guideline;

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified