Trial Information

Summary: A phase II, open-label, non-randomized, multicenter, single agent study of intravenous sdx-102 for the treatment of patients with MTAP - deficient cancers.

The purpose of this study is to determine response rates and safety in patients with MTAP-deficient cancers receiving intravenous SDX-102. The pharmacokinetics of the drug will likewise be studied.

Patients meeting all eligibility requirements will receive SDX-102 as a continuous 5 day IV infusion (CIVI) (120 hours) at a starting dose of 80 mg/m2 daily, repeated every 3 weeks (21-day schedule). Each three-week regimen constitutes a cycle of therapy. Therapy will continue for a maximum of 9 cycles (approximately 6 months).

Blood will be drawn at day 1 and day 6 of SDX-102 infusions for pharmacokinetic evaluation.

Patient Inclusion / Exclusion Criteria:
Tumors of the following types will be included in the study: soft tissue sarcoma, mesothelioma, NSCLC, osteosarcoma and pancreatic cancer. Up to 10 patients per tumor type will be enrolled. The number of allowable prior chemotherapy regimens vary per tumor type. Prior surgery and radiation therapy will be allowed.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.