BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Hoosier Cancer Research Network
Sponsor:
Collaborators:
University of Sydney
Australia New Zealand Gynaecological Oncology Group
Bionomics Limited
Information provided by (Responsible Party):
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT01624493
First received: June 15, 2012
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

This phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse.


Condition Intervention Phase
Ovarian Cancer
Drug: Carboplatin
Drug: Gemcitabine
Drug: BNC105P
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients in First or Second Relapse

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Phase I: Determine Maximum Tolerated Dose for Patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To determine the recommended dose of BNC105P given with gemcitabine and carboplatin (maximum dose of BNC105P with no more than 1 DLT in 6 phase I participants)

  • Phase II: Determine Objective Response Rate in Patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the objective response rate (ORR) in those with evaluable disease (ORR = CR, PR according to RECIST 1.1 and/or GCIG CA125 criteria) (percentage of those with measurable disease achieving CR or PR according to RECIST 1.1 and/or GCIG CA125 criteria)


Secondary Outcome Measures:
  • Progression Free and Overall Survival Distribution [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the progression free and overall survival distribution rates in this patient population

  • Patient Side Effects and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To determine the adverse event rates (Numbers (%) with G2-5 AE (NCI CTCAE v4.0)

  • Patient Quality of Life Benefits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the effects on aspects of health related quality of life (HRQL measured with FOSI and MOST), including symptom benefit (Numbers (%) with significant symptom benefit)

  • Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Plasma will be collected to assess BNC105P pharmacokinetics on days 2 and 9 of cycle 1 only. Results will be compared with data from previous trials of BNC105P to determine their consistency and to establish if there is any major interaction with carboplatin and gemcitabine.

  • Association of Biomarkers, Predictions and Outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the associations between baseline biomarkers, ORR, PFS, OS and AE


Estimated Enrollment: 134
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase II Arm A
Phase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P
Drug: Carboplatin
Carboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles.
Drug: Gemcitabine
Gemcitabine escalations 800 and 1000 mg/m2 (as determined in phase I) on days 1 and 8 of a 21 day cycle, for a maximum of 6 cycles.
Experimental: Phase II Arm B
Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P
Drug: Carboplatin
Carboplatin AUC 4 on day 1 of a 21 day cycle, for a maximum of 6 cycles.
Drug: Gemcitabine
Gemcitabine 800 or 1000 mg/m2 (as determined in phase I) on days 1 and day 8 of 21-day cycle, for a maximum of 6 cycles.
Drug: BNC105P
BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Phase I Only:

  • Histologically or cytologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, including all histological subtypes and carcinosarcoma.

Inclusion Criteria for Phase II Only:

  • Histologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
  • Progression-free interval between 4 to 9 months after first line chemotherapy or 4 to 12 months after second-line chemotherapy with a platinum (cisplatin or carboplatin) based regimen.
  • Subjects must have progressed (based on GCIG CA125 and/or RECIST criteria) after last platinum based regimen.
  • Subjects must be assessable for response based on GCIG CA125 and/or RECIST criteria.
  • Subjects with clinically evident ascites and/or pleural effusions must be assessable by RECIST.
  • Study treatment both planned and able to start within 7 days of randomisation

Exclusion Criteria for Phases I and II:

  • Non-epithelial ovarian cancer and ovarian tumours of low malignant potential (borderline tumours)
  • More than two prior chemotherapy regimens for ovarian cancer (excluding hormonal therapy or biologic agents).
  • Any prior chemotherapy for other cancers, but >10 years permitted for phase II only, except for high dose chemotherapy/autologous or allogeneic transplantation
  • Chemotherapy within 20 days prior to registration.
  • Hormonal therapy or biologic therapy within 28 days prior to registration
  • Concurrent treatment with any experimental drugs or other anti-cancer therapy.
  • Concurrent treatment with clopidogrel, ticlopidine, persantin and other antiplatelet agents
  • Radiotherapy within 21 days prior to registration, or to greater than 15% of the bone marrow.
  • Persistent toxic effects of previous chemotherapy of greater than Grade 1 severity (CTCAE v 4, appendix 8)
  • Known brain or leptomeningeal disease (baseline CT brain or MRI is only required if there is clinical suspicion of central nervous system involvement).
  • Subjects with other invasive malignancies who had (or have) any evidence of another cancer present within the last 3 years, with the exception of early stage non-melanoma skin cancer, carcinoma in situ of cervix, and synchronous endometrial cancer (stage 1 G1,2)
  • Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (unstable angina, congestive cardiac failure, myocardial infarction) within the previous year, or cardiac ventricular arrhythmias requiring medication, or history of 2nd or 3rd degree atrioventricular conduction defects.
  • Cerebrovascular accident or transient ischemic attack within 6 months prior to registration.
  • Poorly controlled hypertension: systolic BP >150 or diastolic BP >100 mmHg. Antihypertensive medications are permitted but BP must be ≤150 systolic and ≤100 diastolic on 2 readings separated by at least 24 hours.
  • Deep vein thrombosis, pulmonary embolism, within 6 months of registration or arterial thrombosis, or arterial embolism within 12 months prior to registration.
  • Receiving full dose, therapeutic anti-coagulation with warfarin, related oral anti-coagulants or unfractionated or low molecular weight heparin. Low dose heparin given for prophylaxis, and aspirin at a dose ≤ 325 mg/day is acceptable.
  • Significant infection including active hepatitis B, hepatitis C with abnormal liver function tests, or HIV. Testing for these is not mandatory. Screening for Hepatitis B should be as per institutional policy. Patients known to be Hep B surface antigen positive will be not be eligible even if on antiviral treatment.
  • Serious medical or psychiatric conditions which might prevent management according to the protocol.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation
  • Pregnancy, lactation, or inadequate contraception. Women must be post menopausal or sterile, or use two reliable means of contraception. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration.
  • Life expectancy of less than 12 weeks.

Exclusion Criteria for Phase II only:

  • Carcinosarcoma and mucinous carcinoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624493

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Meaghan Tenney, M.D.    773-702-6721    mtenney@babies.bsd.uchicago.edu   
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Daniela Matei, M.D.    317-278-0070    dmatei@iupui.edu   
Contact: Kerry Bridges    317-274-2552    kdbridge@iupui.edu   
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Sydney, New South Wales, Australia, 2050
Contact: Julie Martyn    +61 2 9562 5092    julie.martyn@ctc.usyd.edu.au   
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Julie Martyn    +61 2 9562 5092    julie.martyn@ctc.usyd.edu.au   
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 8006
Contact: Julie Martyn    +61 2 9562 5092    julie.martyn@ctc.usyd.edu.au   
New Zealand
Christchurch Hospital Recruiting
Christchurch, Canterbury, New Zealand, 4710
Contact: Julie Martyn    +61 2 9562 5092    julie.martyn@ctc.usyd.edu.au   
Sponsors and Collaborators
Hoosier Cancer Research Network
University of Sydney
Australia New Zealand Gynaecological Oncology Group
Bionomics Limited
Investigators
Study Chair: Danny Rischin, Professor University of Sydney
Principal Investigator: Daniela Matei, M.D. Hoosier Cancer Research Network
  More Information

Additional Information:
No publications provided

Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01624493     History of Changes
Other Study ID Numbers: GYN12-154 / ANZGOG-1103
Study First Received: June 15, 2012
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoosier Cancer Research Network:
Vascular Disrupting Agents
BNC105P
Partially platinum sensitive

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014