NCT01711970

Brief Summary

This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the safety and tolerability of the combination of intravenous administration of VB-111 and paclitaxel in patients with platinum resistant ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

October 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2017

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4.5 years

First QC Date

October 18, 2012

Last Update Submit

April 23, 2020

Conditions

Platinum Resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Define toxicities

    Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.

    2 years

Study Arms (1)

VB-111

EXPERIMENTAL
Drug: Paclitaxel

Interventions

PaclitaxelDRUG
VB-111

Eligibility Criteria

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

You may qualify if:

  • Patients aged \> 18
  • Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian tumors (MMMTs).
  • Must have had prior platinum or platinum based therapy.
  • Eastern Cooperative Oncology Group (ECOG) status 0-1.
  • Platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen
  • Measurable disease
  • Adequate bone marrow and hematological function.
  • Must have recovered from acute toxicity from prior treatment
  • No prior GI perforation, or GI obstruction or involvement of the bowel on imaging
  • Known hypersensitivity to Cremophor EL. However, participants are eligible if they have had a prior paclitaxel reaction, but subsequently tolerated the drug at rechallenge.
  • No patients receiving other investigational therapy for the past 30 days before dosing.

You may not qualify if:

  • More than 3 prior lines of chemotherapy for recurrent cancer.
  • History of other active malignancy, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix within last 2 years.
  • Life expectancy of less than 3 months
  • CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes.
  • Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy.
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  • History of myocardial infarction or unstable angina within 6 months prior to study Day 1.
  • History of stroke or transient ischemic attack within 6 months prior to Day 1.
  • Known CNS disease, except for treated brain metastasis
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1.
  • History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1.
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Related Publications (1)

  • Arend RC, Beer HM, Cohen YC, Berlin S, Birrer MJ, Campos SM, Rachmilewitz Minei T, Harats D, Wall JA, Foxall ME, Penson RT. Ofranergene obadenovec (VB-111) in platinum-resistant ovarian cancer; favorable response rates in a phase I/II study are associated with an immunotherapeutic effect. Gynecol Oncol. 2020 Jun;157(3):578-584. doi: 10.1016/j.ygyno.2020.02.034. Epub 2020 Apr 5.

    PMID: 32265057DERIVED

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

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

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 23, 2012

Study Start

November 1, 2012

Primary Completion

May 3, 2017

Study Completion

May 3, 2017

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)