A Phase 1 interventional study of AGS-8M4 and Pegylated liposomal doxorubicin (PLD) in Carcinoma, Ovarian Cancer and Ovarian Diseases, sponsored by Astellas Pharma Inc. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-27.
Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Treatment
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 4 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
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Exclusion Criteria:
Women with platinum resistent ovarian cancer
Biological: AGS-8M4 · Drug: Pegylated liposomal doxorubicin (PLD)
Women with platinum sensitive ovarian cancer
Biological: AGS-8M4 · Drug: gemcitabine · Drug: carboplatin
IV infusion
IV infusion
IV infusion
IV infusion
Incidence of adverse events
Time frame: Throughout the treatment
Assessment of PK variables
Time frame: Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Incidence of anti-AGS-8M4 antibody formation
Time frame: Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Changes in tumor status per RECIST
Time frame: Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.
Change in CA-125 levels
Time frame: Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U.
This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc