A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Neoplasms
In brief
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
Key facts
- Study ID
- NCT02092792
- Run by
- Genentech, Inc.
- People needed
- 42
- Starts
- 2014-04-01
- Expected to finish
- 2017-07-10
- Last updated by the study team
- 2020-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >/= 18 years
- ECOG performance status of 0 or 1
- Histologically or cytologically documented advanced or metastatic solid tumors for which established therapy either does not exist or has proven ineffective or intolerable
- Measurable disease by RECIST v1.1 with at least one measurable target lesion
You may not qualify if…
- Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DLYE5953A
- Oral kinase inhibitors approved by local regulatory authorities may be used within 2 weeks prior to initiation of DLYE5953A, provided that any clinically relevant drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor
Where it is running
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Yale Cancer Center; Medical Oncology — New Haven, Connecticut, United States
- Dana Farber Cancer Inst. — Boston, Massachusetts, United States
- Karmanos Cancer Center — Detroit, Michigan, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.