Camsirubicin + Pegfilgrastim to Determine MTD in ASTS (NCT05043649) | Clinical Trial Compass
TerminatedPhase 1
Camsirubicin + Pegfilgrastim to Determine MTD in ASTS
Stopped: lack of timely enrollment
United States14 participantsStarted 2021-09-22
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
What they're measuring
1
To determine Maximum Tolerated Dose (MTD)
Timeframe: 3 weeks after first injection
2
Recommended Phase 2 Dose (RP2D) Camsirubicin HCl for Injection
✓. Laboratory tests must be as follows and may be repeated once at the discretion of the investigator:
Exclusion criteria
✕. 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).