| Eligibility |
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for inclusion in this
study:
1. The participant must provide written informed consent prior to performance of
study-specific procedures and must be willing to comply with treatment and follow-up.
Informed consent must be obtained prior to start of the screening process. Procedures
conducted as part of the patient's routine clinical management (e.g., blood count,
imaging tests) and obtained prior to signature of informed consent may be used for
screening or baseline purposes as long as these procedures are conducted as specified
in the protocol.
2. Age =18 years.
3. Only locally confirmed histological diagnosis of advanced unresectable or metastatic
malignant soft tissue sarcoma (including leiomyosarcoma, dedifferentiated liposarcoma,
myxoid liposarcoma, pleomorphic liposarcoma, undifferentiated pleomorphic sarcoma,
malignant peripheral nerve sheath tumor, high-grade sarcoma [not otherwise specified],
or synovial sarcoma) not amenable to curative treatment with surgery or radiotherapy.
4. Presence of measurable disease as defined by the Response Evaluation Criteria in Solid
Tumors version 1.1 (RECIST v1.1).
5. Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
6. The participant has not received any previous treatment with anthracyclines (not even
in adjuvant therapy).
7. The participant has not had any prior systemic cytotoxic therapies for
advanced/metastatic sarcoma and is considered an appropriate candidate for
anthracycline therapy. All previous anticancer treatments must be completed =28 days
prior to first dose of study drug.
8. Laboratory tests must be as follows and may be repeated once at the discretion of the
investigator:
1. Absolute neutrophil count (ANC) =1,500/mm³
2. Platelet count =100,000/mm³
3. Hemoglobin >9 g/dL
4. Bilirubin <1.5 times upper limit of normal (ULN); except subjects with Gilbert
Syndrome who must have a total bilirubin level <3.0 x ULN
5. Prothrombin time (PT) (seconds) or international normalized ratio (INR) =1.5 x
ULN
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x ULN
or, in patients with documented hepatic metastasis, =5 x ULN
7. Serum creatinine =1.5 mg/dL or estimated creatinine clearance =60 mL/min
(Cockroft and Gault)
9. Left ventricular ejection fraction (LVEF) =50% assessed within 28 days prior to
enrollment.
10. Females of childbearing potential must have a negative urine or serum pregnancy test
within 7 days prior to enrollment. A female is eligible to enter and participate in
the study if she is of non-childbearing potential (i.e., physiologically incapable of
becoming pregnant), including any female who has had a hysterectomy, a bilateral
oophorectomy (ovariectomy), a bilateral tubal ligation, or is postmenopausal with a
minimum of 1 year without menses.
11. Both males and females must agree to use highly effective contraceptive precautions if
conception is possible during the dosing period and up to 3 months following the last
dose of study drug.
12. Female patients who are lactating must agree to discontinue nursing prior to the first
dose of study drug and must refrain from nursing throughout the treatment period and
for 3 months following the last dose of study drug.
13. The participant has, in the opinion of the investigator, a life expectancy of at least
3 months.
Exclusion Criteria:
Patients must not meet any of the exclusion criteria to be eligible for study
participation.
1. 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, or clear cell sarcomas.
2. Patients who cannot tolerate pegfilgrastim.
3. Known active central nervous system (CNS) or leptomeningeal metastasis (brain
metastasis) at the time of enrollment. Participants with a history of a CNS metastasis
previously treated with curative intent (e.g., stereotactic radiation or surgery) that
have not progressed on follow-up imaging, have been asymptomatic for at least 60 days
prior to first dose, and are not receiving systemic corticosteroids and
or/anticonvulsants are eligible. Participants with signs or symptoms of neurological
compromise should have appropriate radiographic imaging performed before enrollment to
rule out brain metastasis.
4. Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines
or anthracenediones (including adjuvant therapy).
5. Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.
Other thoracic radiotherapy is permitted.
6. The participant has symptomatic congestive heart failure (CHF), left ventricular
ejection fraction dysfunction (LVEF <50%), severe myocardial insufficiency, cardiac
arrhythmia (uncontrolled, clinically significant), or cardiomyopathy.
7. The participant has unstable angina pectoris, angioplasty, cardiac stenting, or
myocardial infarction within 6 months of enrollment.
8. The participant has a QT interval calculated using Fridericia's correction (QTcF) of
>450 milliseconds (msec) for males and >470 msec for females on screening
electrocardiogram (ECG).
9. Females who are pregnant or breastfeeding.
10. Known allergy to any of the treatment components including a history of allergic
reactions attributed to compounds of chemical or biological composition similar to
doxorubicin and camsirubicin, including intravenous (IV) lactose, or pegfilgrastim.
11. The participant has a known, uncontrolled active fungal, uncontrolled bacterial, or
uncontrolled viral infection including human immunodeficiency virus (HIV) or viral
hepatitis (B or C).
12. Any malignancy other than soft tissue sarcoma within the last 5 years prior to
screening, with the exception of:
1. Cervical carcinoma in situ or
2. Basal cell carcinoma or
3. Superficial bladder tumors that have been successfully and curatively treated
with no evidence of recurrent or residual disease.
13. Unstable or clinically significant concurrent medical condition that would, in the
opinion of the investigator, confound the assessment of camsirubicin's effect,
jeopardize the safety of a patient and/or their compliance with the protocol.
14. Currently receiving any investigational agents.
|
