Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/7/2015 |
| Start Date: | March 2015 |
| End Date: | September 2017 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma
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.
combination is safe and has beneficial effects in patients with liposarcoma.
Inclusion Criteria:
- Patients with histologically documented, locally advanced or metastatic WD/DD
liposarcoma who have received at least one prior systemic therapy
- Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or
within 6 months after last systemic treatment, prior to enrollment
- ECOG performance status of 0-1
Exclusion Criteria:
- Prior treatment with compounds with the same mode of action
- Patients with TP53 mutated tumors, if the molecular status is known
- Symptomatic central nervous system metastases
- Inadequate organ function
- Previous and concomitant therapy that precludes enrollment, as defined by protocol
Other protocol-defined inclusion/exclusion criteria may apply.
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