Phase 3 Study to Treat Patients With Soft Tissue Sarcomas

Not Recruiting

Trial ID: NCT02049905


The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.

Official Title

A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)


Inclusion Criteria:

   1. Has provided written informed consent prior to any study related activities.

   2. Age ≥15 years (US only), and 18-80 (rest of world (ROW)), male or female.

   3. Histological confirmation of intermediate or high grade soft-tissue sarcoma. Tissue
   must be sent to a central pathology lab for review but will not preclude entry onto
   the study. Final assignment of tumor grade and histology will be based on the
   designation provided by the central pathology review.

   4. An adequate tumor specimen obtained by either excisional biopsy, incisional biopsy or
   core needle biopsy must be sent to the central pathology lab for evaluation. The
   material must measure at least 0.8 × 0.1 cm in size or contain at least 50 tumor

   5. Locally advanced, unresectable, and/or metastatic soft-tissue sarcoma of intermediate
   or high grade with evidence of disease progression by either computed tomography (CT)
   or magnetic resonance imaging (MRI) scan, or clinical judgment on or after the last
   cancer therapy within 6 months prior to randomization.

   6. Relapsed or refractory (lack of response) to ≥1 course of systemic therapy regimen(s),
   excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or

   7. Capable of providing informed consent and complying with trial procedures.

   8. ECOG PS 0-2.

   9. Life expectancy >12 weeks.

10. Measurable tumor lesions according to RECIST 1.1 criteria.[50]

11. Women must not be able to become pregnant (e.g., post-menopausal for at least 1 year,
   surgically sterile, or practicing adequate birth control methods) for the duration of
   the study. (Adequate contraception includes: oral contraception, implanted
   contraception, intrauterine device implanted for at least 3 months, or barrier method
   in conjunction with spermicide.)

12. Males and their female partner(s) of child-bearing potential must use 2 forms of
   effective contraception (see Inclusion 11 plus condom or vasectomy for males) from the
   last menstrual period of the female partner during the study treatment and agree to
   continue use for 6 months after the final dose of study treatment.

13. Women of child bearing potential must have a negative serum or urine pregnancy test at
   the Screening Visit and be non-lactating.

14. Accessibility to the site that optimizes the subject's ability to keep all
   study-related appointments.

Exclusion Criteria:

   1. Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.

   2. Palliative surgery and/or radiation treatment within 30 days prior to date of

   3. Exposure to any investigational agent within 30 days of date of randomization.

   4. Exposure to any systemic chemotherapy within 30 days of date of randomization.

   5. An inadequate tumor specimen as defined by the central pathologist.

   6. Current evidence/diagnosis of alveolar soft part sarcoma, extraskeletal myxoid
   chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST),
   dermatofibrosarcoma (unless transformed to fibrosarcoma), Ewing's sarcoma, Kaposi's
   sarcoma, mixed mesodermal tumor, clear cell sarcomas.

   7. Evidence of central nervous system (CNS) metastasis who have not received prior
   definitive therapy for their lesions.

   8. History of other malignancies except cured basal cell carcinoma, cutaneous squamous
   cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of
   the cervix unless documented free of cancer for ≥5 years.

   9. Laboratory values: Screening serum creatinine >1.5 x upper limit of normal (ULN),
   alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total
   bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration
   <100,000/mm3, hemoglobin <9g/dL.

10. Clinically evident congestive heart failure (CHF) > class II of the New York Heart
   Association (NYHA) guidelines.

11. Current, serious, clinically significant cardiac arrhythmias, defined as the existence
   of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.

12. Baseline QTc >470 msec and/or previous history of QT prolongation while taking other

13. Concomitant use of medications associated with a high incidence of QT prolongation is
   not allowed.

14. History or signs of active coronary artery disease with or without angina pectoris
   within the last 6 months.

15. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection
   fraction (LVEF) below the institution's lower limit of predicted normal.

16. Known history of HIV infection.

17. Active, clinically significant serious infection requiring treatment with antibiotics,
   anti-virals or anti-fungals. The Medical Monitor should be contacted for any

18. Major surgery within 30 days prior to date of randomization.

19. Current or past substance abuse or any condition that might interfere with the
   subject's participation in the study or in the evaluation of the study results.

20. Any condition that is unstable and could jeopardize the subject's participation in the


drug: Aldoxorubicin

drug: Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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