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

NCT02092792 | Completed Phase 1

• 1 other identifier: GO29146
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicities

  Days 1 to 21

• Incidence of adverse events

  Up to 32 months

Secondary Outcomes (5)

• Total exposure of the drug, defined as the area under the concentration-time curve (AUC)

  Up to 32 months

• Incidence of anti-DLYE5953A antibodies

  Up to 32 months

• Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1

  Up to 32 months

• Duration of objective response

  Up to 32 months

• Progression-free survival

  Up to 32 months

Study Arms (2)

Dose-Escalation Phase

EXPERIMENTAL

Drug: DLYE5953A

Dose-expansion cohort

EXPERIMENTAL

Drug: DLYE5953A

Interventions

DLYE5953A DRUG

Escalating doses of DLYE5953A

Dose-Escalation Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (5)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Yale Cancer Center; Medical Oncology

New Haven, Connecticut, 06520, United States

Location

Dana Farber Cancer Inst.

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: April 1, 2014
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

US (5)