NCT02210663

Brief Summary

This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2014

Typical duration for phase_1

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

July 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 7, 2018

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

July 25, 2014

Last Update Submit

May 2, 2018

Conditions

Advanced Solid Tumors

Keywords

Breast cancerPARPPrimary peritoneal cancerFallopian tubeOvarian cancerveliparibABT-888BRCA

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicities of veliparib

    During the first cycle (28 days) of veliparib administration

Secondary Outcomes (7)

  • Change in participant physical exam measurements

    Approximately 1 year

  • Change in participant clinical lab results

    Approximately 1 year

  • Number of participants with adverse events

    Approximately 1 year

  • Preliminary tumor response

    Participants will be followed for the duration of an expected average of 8 months.

  • Maximum observed plasma concentration (Cmax)

    For 24 hours following veliparib dosing.

  • +2 more secondary outcomes

Study Arms (1)

veliparib (ABT-888)

EXPERIMENTAL
Drug: veliparib (ABT-888)

Interventions

veliparib (ABT-888)DRUG

Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.

Also known as: veliparib, ABT-888
veliparib (ABT-888)

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed malignant solid tumor, and any of the following: \* Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; \* Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; \* Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy of greater than 12 weeks.
  • Adequate organ and marrow function· Measurable or non-measurable disease.

You may not qualify if:

  • Major surgery and/or radiation within (\<) 4 weeks prior to study enrollment.
  • Chemotherapy or hormone therapy within (\<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks.
  • Any investigational agents within (\<) 4 weeks prior to study enrollment.
  • Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
  • Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site Reference ID/Investigator# 128056

Hidaka-shi, Japan

Location

Site Reference ID/Investigator# 129976

Hyōgo, Japan

Location

Site Reference ID/Investigator# 128057

Tokyo, Japan

Location

Related Publications (1)

  • Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.

    PMID: 28665051RESULT

MeSH Terms

Conditions

Breast NeoplasmsOvarian Neoplasms

Interventions

veliparib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Hideyuki Hashiba, BS

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

August 7, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

May 7, 2018

Record last verified: 2016-07

Locations

JP(3)