PK and Safety of Paclitaxel Injection Concentrate for Nano-dispersion Alone and in Carboplatin Combination

Overview

About this study

This is a phase I study of PICN alone and in combination with carboplatin and consisting of 2 sequential parts.

Part A will characterize the pharmacokinetic profile of PICN at 3 dose levels administered as 30-min infusion to separate groups of 3 subjects with advanced solid malignancy.

Part B will start upon completion of Part A and will use the standard '3+3' dose-escalation design to determine the MTD and recommend phase II dose of PICN in combination with carboplatin.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Part A: Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option. Part B: Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which platinum/taxane-based combination therapy is a rational treatment option.
  • Age ≥18 years
  • ECOG Performance Status ≤ 1.
  • Estimated life expectancy of at least 12-weeks;
  • Measurable disease as per RECIST guideline (Version 1.1);
  • Adequate organ and immune system function as indicated by laboratory tests obtained ≤ 2 weeks prior to dosing.
  • Women of child bearing potential practicing an acceptable method of birth control.
  • Willing to participate and give written informed consent.

Exclusion Criteria:

  • Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or in situ cervical cancer (CIS)
  • 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
  • Pre-existing peripheral neuropathy (grade 1 or higher)
  • Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Steven Alberts, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Steven Alberts, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20145175

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