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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT02092792
First received: March 18, 2014
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This is an open-label, multicenter, Phase I study to evaluate the safety, tolera bility, and PK of escalating doses of DLYE5953A administered to patients with in curable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escala tion and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escala tion design will be used to examine the safety, tolerability, and PK of increasi ng doses of DLYE5953A. In Stage 2, patients will be enrolled to further characte rize the safety, tolerability, and PK of the proposed dose and schedule for futu re studies.


Condition Intervention Phase
Neoplasms
Drug: DLYE5953A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE I, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF ESCALATING DOSES OF DLYE5953A IN PATIENTS WITH REFRACTORY SOLID TUMORS

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities [ Time Frame: Days 1 to 21 ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: Up to 32 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total exposure of the drug, defined as the area under the concentration-time curve (AUC) [ Time Frame: Up to 32 months ] [ Designated as safety issue: No ]
  • Incidence of anti-DLYE5953A antibodies [ Time Frame: Up to 32 months ] [ Designated as safety issue: No ]
  • Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 [ Time Frame: Up to 32 months ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: Up to 32 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 32 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: April 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02092792

Contacts
Contact: Reference Study ID Number: GO29146 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT02092792     History of Changes
Other Study ID Numbers: GO29146
Study First Received: March 18, 2014
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014