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NCT Number: NCT02092792

A Study Evaluating the Safety 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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Cancer Center, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DLYE5953A

Drug

Escalating doses of DLYE5953A

Primary outcomes

  1. Incidence of dose-limiting toxicities

    Time frame: Days 1 to 21

  2. Incidence of adverse events

    Time frame: Up to 32 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2014
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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