A Study to Evaluate the Safety, Tolerability, Drug/Body Interactions, and Activity of Oradoxel for Patients with Advanced Malignancies

Overview

About this study

The purpose of this study is to determine the safety, tolerability, activity, and drug/body interactions of Oradoxel for the treatment of patients who have advanced malignancies.

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:

  • Signed written informed consent.
  • Age ≥ 18 years old.
  • Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Docetaxel monotherapy is a reasonable treatment in the judgement of the Investigator.
  • Measurable disease as per RECIST v1.1 criteria.
  • Able to swallow oral medication as an intact dosage form.
  • Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain an absolute neutrophil count (ANC) ≥ 1500 cells/mm^3, platelet count ≥ 100 x 10^9/L, or hemoglobin (Hgb) ≥ 10 g/dL.
  • Adequate liver function as demonstrated by a total bilirubin of < upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN, alkaline phosphatase (ALP) ≤ 2.5 x ULN or < 5 x ULN if bone metastases are present, and normal serum albumin.
  • Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN or creatinine clearance>60 mL/min as calculated by the Cockroft and Gault formula.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of at least 3 months.
  • Willing to fast for 6 hours before and 2 hours after Oradoxel administration.
  • Females must be postmenopausal (> 12 months without menses) or surgically sterile (i.e., by hysterectomy and/or bilateral oophorectomy).
    • If sexually active, must be using effective contraception (i.e., oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug.
  • Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.

Exclusion Criteria:

  • Currently taking a prohibited concomitant medication, other than a premedication, that are/is:
    • Strong inhibitors (e.g., ketoconazole) or inducers (e.g., rifampicin or St. John's Wort) of CYP3A45 (within 2 weeks prior to the start of dosing in the study);
    • Strong P-gp inhibitors or inducers.  Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ≥ 1 week before dosing and remain off that medication through the end of PK sampling after the administration of the second study treatment;
    • An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study.
  • Unresolved toxicity from prior chemotherapy (subjects must be recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products.
  • Planning to receive other medical, surgical, or radiological cancer treatments during the course of this study.
  • Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer.
  • Require therapeutic use of anticoagulants.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant myocardial infarction within the last 6 months, unstable angina pectoris, clinically significant cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator, may interfere with oral drug absorption.
  • A known history of allergy to docetaxel, Cremophor or polysorbate 80 (Tween 80).
  • Evidence of fluid retention at screening (including, for example, peripheral edema, pleural effusion, or ascites on physical or radiological examination) or history of severe capillary leak syndrome.
  • Any other condition which the Investigator believes would make participation in the study not acceptable.

 

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

Wen Wee Ma, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Parminder Singh, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions