A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2010 |
| End Date: | June 2015 |
A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors
This first-in-human dose-escalation study is to characterize the safety, tolerability,
pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in
patients with advanced solid tumors.
pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in
patients with advanced solid tumors.
Inclusion Criteria:
- Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma
or locally advanced or metastatic basal cell carcinoma)
- Protocol defined laboratory parameters
- Performance status ≤ 2
- Patients must have fully recovered from the prior effects of major surgery and from
any acute toxicities of prior chemotherapy/radiotherapy
Exclusion Criteria:
- History of central nervous system tumors of symptomatic brain metastases (excludes
medulloblastoma patients)
- Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
- Impairment of cardiac function or significant cardiac disease
- Pregnant or lactating women
- Other protocol-defined inclusion/exclusion criteria may apply
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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