Status:
TERMINATED
TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in vivo models. Parti...
Detailed Description
Despite impressive progress in the fields of surgical and immunological cancer therapies, most late-stage cancer treatments still heavily depend on conventional chemotherapeutics, which are often effe...
Eligibility Criteria
Inclusion
- Key inclusion criteria for dose escalation part:
- Final protocol until amendment 2: Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor who failed standard therapy or for whom no effective standard therapy is available
- From Amendment 3 on: Patients with histologically or cytologically confirmed advanced malignant tumors of the breast, ovary, uterine or sarcoma who failed standard therapy or for whom no effective standard therapy is available.
- Patients may have received up to 3 prior lines of palliative systemic chemotherapy
- Patients with brain metastases must have undergone definitive treatment (surgery and/or radiation) at least 1 month prior to starting study drug and be documented as having stable disease by imaging and are on stable doses of steroids for at least 2 weeks.
- Adequate bone marrow, renal and hepatic function
- Key inclusion criteria for comparative PK part:
- Patients with either histologically or cytologically confirmed advanced or recurrent breast or ovarian cancer of all histologies
- Histologically-confirmed ovarian, fallopian tube or primary peritoneal cancer (collectively referred to herein as 'ovarian cancer') that is either platinum-resistant (disease progression within 6 months of the last receipt of platinum-based chemotherapy) or refractory (lack of response or disease progression while receiving the most recent platinum-based therapy).
- Patients with ovarian cancer may have received up to 3 lines of prior cytotoxic chemotherapy, but maximum 1 of them in the platinumresistant/ refractory setting. Confirmed high-grade serous, endometrioid, or carcinosarcoma histotypes are permitted.
- Patients with advanced or recurrent breast cancer may have received up to 2 prior lines of palliative cytotoxic chemotherapy.
- Patients with brain metastases must have undergone definitive treatment (surgery and/or radiation) at least 1 month prior to starting study drug and be documented as having stable disease by imaging and be on stable doses of steroids for at least 2 weeks.
- Adequate bone marrow, renal and hepatic function
- Key exclusion criteria for dose escalation and comparative PK part:
- Significant cardiac disease or abnormality
- Patients who have received prior anthracyclines at a cumulative dose that exceeds 250mg/m2 for non-liposomal doxorubicin, 300mg/m2 for liposomal doxorubicin or 400mg/m2 for epirubicin and/or are refractory (during 3 months) to anthracyclines or have experienced allergic reactions or severe toxicity (grade 3 or 4) under anthracyclines
- Prior systemic chemotherapy/treatment for adjuvant/metastatic disease, radiotherapy, immunotherapy, or investigational agents within 28 days 5 half- life periods of previous therapy before registration.
Exclusion
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03387917
Start Date
November 12 2018
End Date
December 22 2023
Last Update
December 2 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
2
Inselspital Bern
Bern, Switzerland, CH-3010
3
Kantonsspital Graubünden
Chur, Switzerland, 7000
4
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007