Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
Phase: Phase 3
Diagnosis: Sarcoma, Pediatric Sarcoma
NCT ID: NCT02049905
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-127
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.
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital
Edwin Choy, MD,
Massachusetts General Hospital
James Butrynski, MD,
Dana Farber Cancer Institute
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Dana-Farber Cancer Institute:
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 radiation.
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.
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
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
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
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