Study of ABT-767 in Subjects With Breast Cancer 1 and Breast Cancer 2 (BRCA 1 and BRCA 2) Mutations and Solid Tumors or High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT01339650 | Completed Phase 1

• 2 other identifiers: M10-9762010-020795-37
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or BRCA2)-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

Fallopian Tube; Primary Peritoneal Cancer; Solid Tumors (e.g. Breast, Ovarian, Prostate, or Pancreatic) and Ovarian

Keywords

Solid Tumor; BRCA 1 and BRCA 2 Mutations; Breast Cancer 1; Breast Cancer 2; High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancers; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile

  Blood samples for pharmacokinetics of ABT-767 will be collected at designated time points

  Various time points from Cycle 1 Day -4 to Day 8

Secondary Outcomes (1)

• Safety (number of subjects with adverse events and/or dose limiting toxicities)

  Weekly for the first two months, every other week for the third month, and monthly there after. An expected average is 5 months.

Study Arms (1)

ABT-767

EXPERIMENTAL

ABT-767 monotherapy

Drug: ABT-767

Interventions

ABT-767 DRUG

ABT-767 once or twice daily for a 28 day cycle

ABT-767

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be ≥ 18 years of age.
• Subjects must have histological or cytological confirmation of locally advanced or metastatic solid tumor, and a documented Breast Cancer Gene 1 or 2 mutation, or high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2
• Subjects must have adequate hematologic, renal, and hepatic function as follows: a. Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3 (1.5 ≥ 109/L); Platelets ≥ 100,000/mm3 (100 ≥ 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L) (hemoglobin unsupported by transfusion b. Subject has adequate renal function as demonstrated by serum creatinine value of ≤ 1.5 x the upper limit of normal (ULN) and either an estimated creatinine clearance value of ≥ 50 mL/min as determined by the Cockcroft-Gault formula or a creatinine clearance value of ≥ 50 mL/min/1.73 m2 based on a 24-hour urine collections c. Subject has adequate liver function as demonstrated by serum bilirubin ≤ 1.5 x ULN and Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 ULN. For subjects with liver metastasis, AST and ALT \< 5 x ULN. Partial Thromboplastin Time (PTT) must be ≤ ULN and INR \< 1.5. - Subjects on anticoagulant (such as Coumadin) are allowed on study and will have PTT and International Normalize Ratio (INR) as determined by the Investigator.
• Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of the study participation, and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to initiation of treatment and a negative urine pregnancy test on the first day of study drug administration. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.

You may not qualify if:

• Expanded cohort only: Subject has previously received a poly (ADP-ribose) polymerase (PARP) inhibitor.
• Subject has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within a period of 28 days or 5 half lives (whichever is shorter) prior to Study Day 1.
• Subject has known Central Nervous System (CNS) metastases.
• Subject has unresolved toxicities from prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.0) grade 2 or higher clinically significant toxicity (excluding alopecia).
• Subject has had major surgery within 28 days prior to Study Day 1.
• Clinically significant uncontrolled condition(s) or any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities.
• Psychiatric illness/social situation that would limit compliance with study requirements.
• Lactating or pregnant female.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (3)

Univ Med Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Univ Med Ctr, St. Radboud

Nijmegen, 6525 GA, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Fanconi Anemia, Complementation Group D1

Interventions

ABT-767

Study Officials

• AbbVie Inc.

  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: April 4, 2011
• First Posted: April 21, 2011
• Study Start: May 6, 2011
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: January 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)