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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2017-07-10

Brief Summary

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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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Detailed Description

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Conditions

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Neoplasms

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose-Escalation Phase

Group Type EXPERIMENTAL

DLYE5953A

Intervention Type DRUG

Escalating doses of DLYE5953A

Dose-expansion cohort

Group Type EXPERIMENTAL

DLYE5953A

Intervention Type DRUG

Administration of DLYE5953A at the recommended phase II dose (RP2D)

Interventions

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DLYE5953A

Escalating doses of DLYE5953A

Intervention Type DRUG

DLYE5953A

Administration of DLYE5953A at the recommended phase II dose (RP2D)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No