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Completed

NCT Number: NCT02210663

A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

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.

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Key information

Conditions

Advanced Solid Tumors Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 128056, Hidaka-shi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

veliparib (ABT-888)

Drug

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

Other names: veliparib, ABT-888

Primary outcomes

  1. Dose-limiting toxicities of veliparib

    Time frame: During the first cycle (28 days) of veliparib administration

Secondary outcomes

  1. Change in participant physical exam measurements

    Time frame: Approximately 1 year

    Blood pressure, pulse and body temperature

  2. Change in participant clinical lab results

    Time frame: Approximately 1 year

    Hematology, Chemistry and Urinalysis

  3. Number of participants with adverse events

    Time frame: Approximately 1 year

    Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03

  4. Preliminary tumor response

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

    According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

  5. Maximum observed plasma concentration (Cmax)

    Time frame: For 24 hours following veliparib dosing.

    Maximum observed concentration, occurring at Tmax

  6. The time to Cmax (peak time, Tmax)

    Time frame: For 24 hours following veliparib dosing.

    The time at which maximum plasma concentration (Cmax) is observed.

  7. The area under the plasma concentration-time curve (AUC)

    Time frame: For 24 hours following veliparib dosing.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2014
Registry last updated
May 7, 2018

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

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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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