Camsirubicin + Pegfilgrastim to Determine MTD in ASTS

Stopped early · Phase 1

Conditions studied: Advanced Soft-tissue Sarcoma

In brief

This is an Interventional Study in Advanced Soft Tissue Sarcomas (ASTS). It is a Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. The objective of the study is to evaluate the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of ASTS and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of camsirubicin with prophylactic pegfilgrastim. The primary endpoint is the MTD (RP2D).The secondary endpoints are: safety profile of camsirubicin with prophylactic pegfilgrastim, PFS, TTP, ORR, DoR, OS and PK. As exploratory endpoint, Quality of life will be measured by using the Functional Assessment of Cancer Therapy: General (FACT-G).

Key facts

Study ID

NCT05043649

Run by

Monopar Therapeutics

People needed

14

Starts

2021-09-22

Expected to finish

2024-05-13

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria to be eligible for inclusion in this study:
• 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.
• Age ≥18 years.
• 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.
• Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• The participant has not received any previous treatment with anthracyclines (not even in adjuvant therapy).
• 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.
• Laboratory tests must be as follows and may be repeated once at the discretion of the investigator:
• Absolute neutrophil count (ANC) ≥1,500/mm³
• Platelet count ≥100,000/mm³
• Hemoglobin >9 g/dL
• 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
• Prothrombin time (PT) (seconds) or international normalized ratio (INR) ≤1.5 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN or, in patients with documented hepatic metastasis, ≤5 x ULN
• Serum creatinine ≤1.5 mg/dL or estimated creatinine clearance ≥60 mL/min (Cockroft and Gault)
• Left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to enrollment.
• 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.
• 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.
• 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.
• The participant has, in the opinion of the investigator, a life expectancy of at least 3 months.

You may not qualify if…

• Patients must not meet any of the exclusion criteria to be eligible for study participation.
• 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.
• Patients who cannot tolerate pegfilgrastim.
• 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.
• Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones (including adjuvant therapy).
• Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation. Other thoracic radiotherapy is permitted.
• 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.
• The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of enrollment.
• 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).
• Females who are pregnant or breastfeeding.
• 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.
• 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).
• Any malignancy other than soft tissue sarcoma within the last 5 years prior to screening, with the exception of:
• Cervical carcinoma in situ or
• Basal cell carcinoma or
• Superficial bladder tumors that have been successfully and curatively treated with no evidence of recurrent or residual disease.
• 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.
• Currently receiving any investigational agents.

Where it is running

• Sarcoma Oncology Center — Santa Monica, California, United States
• University of Washington Medicine Fred Hutchinson Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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