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

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ClinicalTrials.gov Identifier: NCT02092792
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: DLYE5953A Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017
Arms and Interventions
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Arm Intervention/treatment
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)


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092792


Locations
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United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02092792    
Other Study ID Numbers: GO29146
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020