Phase II trial in platinum-refractory ovarian cancer: a randomized multicenter trial with SU11248 to evaluate dosage, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy

AGO Research GmbH0 sites72 target enrollmentJuly 3, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Platinum refractory or resistant ovarian cancer, primary cancer of the peritoneum or fallopian tube (defined as stable (SD) or progressive disease (PD) during platinum containing chemotherapy, or treatment free interval < 6 months after stop of platinum based chemotherapy)
Sponsor: AGO Research GmbH
Enrollment: 72
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

July 3, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Women, 18 years and older, written (signed and dated) informed consent
•Histological confirmed epithelial ovarian cancer, primary cancer of the peritoneum or fallopian tube
•Up to three prior chemotherapies, at least one platinum based chemotherapy
•Platinum refractory or resistant ovarian cancer (defined as stable (SD) or progressive disease (PD) during platinum containing chemotherapy, or treatment free interval \< 6 months after stop of platinum based chemotherapy)
•Measurable or non\-measurable disease
•Elevated CA°125 level (\> 2 x ULN in case of normal CA°125 after prior chemotherapy; or \= 2 x nadir CA°125 value after prior chemotherapy, when CA°125 levels remained elevated above normal) in case of non\-measurable disease
•ECOG performance status 0\-2
•Negative pregnancy test within 5 days before randomization and adequate contraception in women with childbearing potential
•Adequate organ function as defined by the following criteria:
•Serum aspartate aminotransferase (AST; serum glutamate\-oxalate transferase \[SGOT]) and serum alanine aminotransferase (ALT; serum glutamate\-pyruvate transferase \[SGPT]) ?2\.5 x upper limit of normal (ULN). If liver function abnormalities are due to underlying malignancy, then AST and ALT may be ?5 x ULN

•Borderline tumor of the ovaries
•Acute or chronic infection
•Any required concurrent cancer chemotherapy or antineoplastic endocrine therapy or radiotherapy
•Exposure to investigational trial medication, cancer chemo\- or radiotherapy within the last 28 days prior to start of study treatment
•Known or suspected hypersensitivity to investigational compound
•Second malignancy interfering with prognosis of the patient
•Inadequate renal function (Creatinine \>1\.5 x ULN)
•Inadequate hepatic function (ASAT, ALAT, GGT \>2\.5 x ULN, in case of liver metastases \>5\.0 x ULN; Bilirubine \>1\.5 x ULN)
•Platelets \< 100\.000 /µl; ANC \< 1\.500 /µl
•Cachectic patients with a body weight \<45 kg