A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors

Neoplasms Clinical Trial

Official title:

A PHASE I, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF ESCALATING DOSES OF DLYE5953A IN PATIENTS WITH REFRACTORY SOLID TUMORS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092792
• Other study ID #: GO29146
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2014
• Est. completion date: July 10, 2017

Study information

• Verified date: February 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• DLYE5953A
Escalating doses of DLYE5953A
• DLYE5953A
Administration of DLYE5953A at the recommended phase II dose (RP2D)

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Dana Farber Cancer Inst.	Boston	Massachusetts
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Yale Cancer Center; Medical Oncology	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities		Days 1 to 21
Primary	Incidence of adverse events		Up to 32 months
Secondary	Total exposure of the drug, defined as the area under the concentration-time curve (AUC)		Up to 32 months
Secondary	Incidence of anti-DLYE5953A antibodies		Up to 32 months
Secondary	Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1		Up to 32 months
Secondary	Duration of objective response		Up to 32 months
Secondary	Progression-free survival		Up to 32 months