A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | April 1, 2014 |
| End Date: | July 10, 2017 |
A PHASE I, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF ESCALATING DOSES OF DLYE5953A IN PATIENTS WITH REFRACTORY SOLID TUMORS
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
5
sites
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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