SAKK 65/16 Phase 1 Studie mit dem neuen liposomalen Doxorubicin TLD-1 in Patienten mit fortgeschrittenen soliden Tumoren

Drug: TLD-1;Drug: Caelyx

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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.