NCT01682473

Brief Summary

To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

September 20, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2015

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2015

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

September 4, 2012

Last Update Submit

July 3, 2017

Conditions

Neoplasms

Keywords

PI3K inhibitorclinical trial

Outcome Measures

Primary Outcomes (1)

  • Number of participants with dose-limiting toxicities

    28 days

Secondary Outcomes (1)

  • Pharmacokinetics (Cmax, tmax, t½, AUC)

    28 days

Study Arms (2)

Arm 1: 5/2 Dosing

EXPERIMENTAL

Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug.

Drug: ZSTK474

Arm 2: 21/7 Dosing

EXPERIMENTAL

Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug.

Drug: ZSTK474

Interventions

ZSTK474DRUG

Two arms, each with serial cohorts receiving escalating doses.

Arm 1: 5/2 DosingArm 2: 21/7 Dosing

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese males or females \>= 20 years old
  • Advanced (metastatic or unresectable) solid tumor
  • ECOG performance status score of 0 or 1 and expected survival \>12 weeks
  • Recovered from hematological toxicities of prior cancer therapies

You may not qualify if:

  • Previous treatment with PI3K inhibitor
  • Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
  • Other investigational agent within previous 4 weeks
  • Participating in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

ZSTK474

Study Officials

  • Toshihiko Doi, MD, PhD

    National Cancer Center Hospital East

    PRINCIPAL INVESTIGATOR

  • Shunji Takahashi, MD

    The Cancer Institute Hospital of JFCR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 11, 2012

Study Start

September 20, 2012

Primary Completion

April 2, 2015

Study Completion

April 20, 2015

Last Updated

July 6, 2017

Record last verified: 2017-07

Locations

JP(2)