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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: March 18, 2014
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Neoplasms Drug: DLYE5953A Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities [ Time Frame: Days 1 to 21 ]
  • Incidence of adverse events [ Time Frame: Up to 32 months ]

Secondary Outcome Measures:
  • Total exposure of the drug, defined as the area under the concentration-time curve (AUC) [ Time Frame: Up to 32 months ]
  • Incidence of anti-DLYE5953A antibodies [ Time Frame: Up to 32 months ]
  • Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 [ Time Frame: Up to 32 months ]
  • Duration of objective response [ Time Frame: Up to 32 months ]
  • Progression-free survival [ Time Frame: Up to 32 months ]

Enrollment: 42
Study Start Date: April 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-Escalation Phase Drug: DLYE5953A
Escalating doses of DLYE5953A
Experimental: Dose-expansion cohort Drug: DLYE5953A
Administration of DLYE5953A at the recommended phase II dose (RP2D)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02092792

United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Detroit, Michigan, United States, 48201
United States, New York
New York, New York, United States, 10065
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT02092792     History of Changes
Other Study ID Numbers: GO29146
Study First Received: March 18, 2014
Last Updated: November 1, 2016 processed this record on September 21, 2017