Clinical Trial: Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma

Brief Summary: To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

• Phase I: Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]
  DLTs in the first cycle of treatment.
• Phase II: Progression free survival (PFS) [ Time Frame: 12 weeks ]
  To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma
• Phase I: Exposure to HDM201 and LEE011 [ Time Frame: 14 days ]
  as measured by AUC0-24h at C1D14

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of patients with Adverse events [ Time Frame: 6 months ]
  Number of patients with AEs as a measure of Safety and tolerability of HDM201 in combination with LEE011
• Pharmacokinetics (PK) parameters of HDM201 and LEE011 [ Time Frame: up to 18 weeks ]
  PK will be assessed using the composite PK parameters of AUC and Cmax.
• Changes from baseline of Pharmacodynamics (PD) markers [ Time Frame: baseline, 14 days ]
  Changes from baseline of PD markers in tumor tissue and in blood. PDdirect targets of p53 and effectors of CD4.
• Tumor response [ Time Frame: every 6 weeks up to 9 months ]
  On Phase Ib: To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Original Secondary Outcome:

• Number of patients with Adverse events [ Time Frame: 6 months ]
  Number of patients with AEs as a measure of Safety and tolerability of HDM201 in combination with LEE011
• Pharmacokinetics (PK) parameters of HDM201 and LEE011 [ Time Frame: up to 18 weeks ]
  PK will be assessed using the composite PK parameters of AUC and Cmax.
• Changes from baseline of Pharmacodynamics (PD) markers [ Time Frame: baseline, 14 days ]
  Changes from baseline of PD markers in tumor tissue and in blood
• Tumor response [ Time Frame: every 6 weeks ]
  On Phase Ib: To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Information By: Novartis

Dates:
Date Received: January 5, 2015
Date Started: March 13, 2015
Date Completion: December 29, 2018
Last Updated: May 17, 2017
Last Verified: May 2017