A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer

NCT02591095 | Completed Phase 2 DMC

• 1 other identifier: 2015-000193-35
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 16

Brief Summary

ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.

Conditions

Platinum-resistant or Refractory Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer.

  the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.

Secondary Outcomes (6)

• Bim expression level

  biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions

• Response rate

  evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]

• Overall survival (OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.

• Incidence of Treatment-Emergent Adverse Events according to the NCI CTC AE version 4.0

  From date of treatment start until end of study participation (during average 12 months)]

• Peak Plasma Concentration of ABT-263

  8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions

Study Arms (1)

ABT-263

EXPERIMENTAL

oral Navitoclax (ABT-263) daily

Drug: ABT-263

Interventions

ABT-263 DRUG

ABT-263

Eligibility Criteria

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

You may qualify if:

• \- Woman older than 18 years
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Histologically and/or cytologically documented high grade serous epithelial cancer of ovarian, fallopian tube or peritoneum
• Platinum resistant ovarian cancer defined as relapsing within 6 months after a platinum based chemotherapy OR platinum refractory ovarian cancer defined as progressing during a platinum based chemotherapy (excepted refractory patients in first line)
• Subjects having received at least 2 prior lines of treatments including platinum regimen
• Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy before therapy at screening
• There is no limitation to prior number of therapies
• Patients must have documented disease progression
• Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:• Absolute Neutrophil Count ≥ 1500/ mm3
• Platelets ≥ 150,000 / mm3
• Hemoglobin ≥ 9.0 g/dL
• Renal function: Serum creatinine ≤1.2mg/dL or calculated creatinine clearance ≥ 60mL/min
• AST/ALT ≤ 3.0× the upper limit of normal (ULN); \[Subjects with liver metastasis may have AST, ALP, and ALT less then or equal to 5.0 X ULN\]
• Bilirubin ≤ 1.25×ULN

You may not qualify if:

• Patient's refusal or impossibility to perform biopsy on relapsing disease
• Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption
• Patients with platinum refractory disease in first line
• Received radio-immunotherapy within 6 months of 1st dose of study drug
• Received steroid therapy for anti-neoplastic intent within 7 days of the 1st dose of study drug (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed)
• Consumption of grapefruit or grapefruit products within 3 days prior to the first dose of study drug
• Patient receiving treatments strong CYP3A4 inhibitors or inducers (Appendix A)
• Positive for HIV and VHC
• Predisposing condition/currently exhibiting signs of bleeding
• Currently receiving anticoagulation therapy, exception of low-dose anticoagulation medications for prophylaxis
• Received aspirin within 7 days of start dose of study drug
• Active peptic ulcer disease / other potentially hemorrhagic esophagitis/gastritis
• Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or history of being refractory to platelet transfusions (within 1 year of 1st dose of study drug)
• Uncontrolled cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease, active systemic fungal infection; diagnosis of fever and neutropenia within 1 week of study drug administration
• A evidence of current/active malignancies other than ovarian cancer

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• ARCAGY/ GINECO GROUP: collaborator
• French Cancer Research Hospital Program: collaborator

Study Sites (16)

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

Location

Institut Bergonié

Bordeaux, France

Location

Centre Francois Baclesse

Caen, France

Location

Centre Oscar Lambret

Lille, France

Location

Centre Léon Bérard

Lyon, France

Location

CHU

Lyon, France

Location

ICM Val d'Aurelle

Montpellier, France

Location

ICL Institut de Cancérologie de Lorraine

Nancy, France

Location

Centre Catherine de Sienne

Nantes, France

Location

ICO Centre René Gauducheau

Nantes, France

Location

ICO Paul Papin

Nantes, France

Location

Centre Antoine LACASSAGNE

Nice, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Tenon

Paris, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Gustave Roussy

Villejuif, France

Location

Related Publications (1)

• Joly F, Fabbro M, Follana P, Lequesne J, Medioni J, Lesoin A, Frenel JS, Abadie-Lacourtoisie S, Floquet A, Gladieff L, You B, Gavoille C, Kalbacher E, Briand M, Brachet PE, Giffard F, Weiswald LB, Just PA, Blanc-Fournier C, Leconte A, Clarisse B, Leary A, Poulain L. A phase II study of Navitoclax (ABT-263) as single agent in women heavily pretreated for recurrent epithelial ovarian cancer: The MONAVI - GINECO study. Gynecol Oncol. 2022 Apr;165(1):30-39. doi: 10.1016/j.ygyno.2022.01.021. Epub 2022 Feb 2.

  PMID: 35123771 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

navitoclax

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 29, 2015
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: March 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

FR (16)