Trial Search Results

Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

This study investigates a new formulation of paclitaxel (sold as Taxol), known as paclitaxel injection concentrate for nano-dispersion (PICN). This study is currently enrolling in Part A- 2, for patients with cholangiocarcinoma, a type of cancer that starts in the bile ducts or other biliary tract tissues. This is primarily a phase 1, safety, toxicity, and pharmacokinetic (drug levels) study.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Sun Pharma Advanced Research Company Limited

Stanford Investigator(s):

Intervention(s):

  • Drug: SPARC1023 I
  • Drug: SPARC1023 II

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Age ≥18 years

   - ECOG Performance Status ≤ 1.

   - Estimated life expectancy of at least 12-weeks;

   - Measurable disease as per RECIST guideline (Version 1.1);

Exclusion Criteria:

   - Any malignancy within past 5-years, except non-melanoma skin cancer, cervical
   intraepithelial neoplasia, or in situ cervical cancer

   - Known hypersensitivity to the study drugs

   - Treatment with any anti-cancer agents within 28 days of study entry

   - Presence of clinically evident active CNS metastases, including leptomeningeal
   involvement, requiring steroid or radiation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting