NCT01624493

Brief Summary

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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_1 ovarian-cancer

Geographic Reach
3 countries

6 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

June 15, 2012

Last Update Submit

December 21, 2015

Conditions

Ovarian Cancer

Keywords

Vascular Disrupting AgentsBNC105PPartially platinum sensitive

Outcome Measures

Primary Outcomes (2)

  • Phase I: Determine Maximum Tolerated Dose for Patients

    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)

    12 months

  • Phase II: Determine Objective Response Rate in Patients

    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)

    12 months

Secondary Outcomes (5)

  • Progression Free and Overall Survival Distribution

    12 months

  • Patient Side Effects and Tolerability

    12 months

  • Patient Quality of Life Benefits

    12 months

  • Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine

    12 months

  • Association of Biomarkers, Predictions and Outcomes

    12 months

Study Arms (2)

Phase II Arm A

EXPERIMENTAL

Phase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P

Drug: CarboplatinDrug: Gemcitabine

Phase II Arm B

EXPERIMENTAL

Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P

Drug: CarboplatinDrug: GemcitabineDrug: BNC105P

Interventions

CarboplatinDRUG

Carboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles.

Phase II Arm A
GemcitabineDRUG

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.

Phase II Arm A
BNC105PDRUG

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.

Phase II Arm B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

Christchurch Hospital

Christchurch, Canterbury, 4710, New Zealand

Location

Related Publications (2)

  • Danny Rischin, Daniela Matei, Jeffrey C. Goh, Michelle Margaret Vaughan, Philip James Beale, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, David C. Bibby, Jeremy Simpson, Elizabeth E. Doolin, Corinne E. Williams, Martin R. Stockler. A phase I/II study of the vascular disrupting agent BNC105P in combination with gemcitabine-carboplatin in partially platinum-sensitive ovarian cancer patients in first or second relapse: An international collaborative group trial of ANZGOG and HOG. J Clin Oncol 31, 2013 (suppl; abstr TPS5612) http://abstracts2.asco.org/AbstView_132_108013.html

    BACKGROUND

  • Danny Rischin, Philip James Beale, Emma Caroline Rossi, Jeffrey C. Goh, Michelle Margaret Vaughan, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, Gabriel Kremmidiotis, Jeremy Andrew Simpson, Elizabeth E. Doolin, Tina C. Lavranos, Annabell F. Leske, Anne-Sophie Veillard, Martin R. Stockler, ANZGOG and HOG. A phase I study of the vascular-disrupting agent BNC105P in combination with gemcitabine-carboplatin in platinum-sensitive ovarian cancer patients in first or second relapse. J Clin Oncol 32:5s, 2014 (suppl; abstr 5524^). ACTRN12612000522819

    BACKGROUND

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CarboplatinGemcitabineBNC 105P

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Danny Rischin, Professor

    University of Sydney

    STUDY CHAIR

  • Daniela Matei, M.D.

    Hoosier Cancer Research Network

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 20, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

AU(3)US(2)NZ(1)