Clinical Trial: A Safety Study of RTA 744 in Recurrent, Progressive or Refractory Neoplastic Meningitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase I Safety and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent, Progressive or Refractory Neoplastic Meningitis

Brief Summary: This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent neoplastic meningitis.

Detailed Summary:

Neoplastic meningitis refers to the deposition of malignant cells in the lining (leptomeninges) of the brain and spine. Neoplastic meningitis from solid tumors most often occurs in patients with advanced systemic disease who have failed prior chemotherapy; it is also frequent in patients with CNS parenchymal metastasis. Patient survival remains low, and better treatments are needed to penetrate the blood brain barrier and treat the entire neuraxis.

RTA 744 is a close chemical analogue of the well characterized anti-cancer agent doxorubicin. Unlike doxorubicin, RTA 744 has shown ability to cross the blood brain barrier and to achieve high concentration in CNS tumor tissue in animal models. Dose escalation will continue as pre-determined until first occurrence of a dose-limiting toxicity. Maximum tolerated dose will be determined as defined in protocol.


Sponsor: Reata Pharmaceuticals, Inc.

Current Primary Outcome:

  • Determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor. [ Time Frame: evaluation at end of cycle 1 for each cohort ]
  • Characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF in a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose (MTD). [ Time Frame: end of study ]


Original Primary Outcome:

  • Determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor.
  • Characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF in a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose (MTD).


Current Secondary Outcome:

  • Document any potential antitumor activity. [ Time Frame: after every even numbered treatment cycle ]
  • Correlate pharmacokinetic information with clinical (efficacy and safety) responses. [ Time Frame: end of study ]


Original Secondary Outcome:

  • Document any potential antitumor activity.
  • Correlate pharmacokinetic information with clinical (efficacy and safety) responses.


Information By: Reata Pharmaceuticals, Inc.

Dates:
Date Received: September 7, 2007
Date Started: October 2006
Date Completion:
Last Updated: November 12, 2014
Last Verified: November 2014