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A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Mullerian Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Malignant Tumor of Peritoneum, Papillary Carcinoma of Uterus, Uterine Malignant Mixed Muellerian Tumour

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Trial Information

A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Mullerian Cancer

We are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants who have ovarian cancer. For
this reason not everyone who participates in the research study will receive the same dose
of the study drug. The dose you get will depend on the number of participants who have been
enrolled in the study before you and how well they have tolerated their doses.

This study will be performed in cycles. Each cycle will be 28 days long. If you take part in
this research study, you will receive VB-111 as a 15-minute intravenous infusion on Day 1 of
odd cycles (e.g. every 2 cycles, or 2 months). VB-111 will be infused immediately following
the paclitaxel.

You will receive paclitaxel as a 60-minute intravenous infusion weekly (days 1, 8, 15 and 22
of each 4 week cycle).

On Day 1 of each cycle you will undergo a medical history, physical exam, performance
status, vital signs check, urine sample, routine blood tests, biomarker blood tests and
biodistribution blood and urine tests. On Day 1 of each odd cycle you will undergo a CT scan
or MRI to assess your tumor.

After the final dose of VB-111 you will be required to return to the clinic for a follow up
visit. This visit will consist of a medical history, vital signs, physical examination,
performance status, blood samples, urine samples, EKG and measurement of your tumor by CT or
MRI. In the case of unexplained death, we will ask your family's permission for an autopsy.

Inclusion Criteria:

- Up to 3 previous lines of chemotherapy for metastatic disease are allowed

- Must have had prior platinum or platinum based therapy

- Platinum resistant or refractory disease

- Measurable or evaluable disease

- Must have recovered from acute toxicity from prior treatment

Exclusion Criteria:

- Prior GI perforation or GI obstruction or involvement of the bowel on imaging

- Active untreated psychiatric disease or neurologic symptoms requiring treatment

- Known hypersensitivity to Cremophor EL

- Evidence of uncontrolled bacterial, viral or fungal infections

- Receiving other investigational therapy for the past 30 days before dosing

- More than 3 prior lines of chemotherapy for recurrent cancer

- Other active malignancy

- Inadequately controlled hypertension

- NYHA Grade II or greater congestive heart failure

- History of myocardial infarction or transient ischemic attack within 6 months

- Known CNS disease, except for treated brain metastasis

- Significant vascular disease

- History of hemoptysis within 1 month

- Evidence of bleeding diathesis or significant coagulopathy

- Major surgical procedure within 28 days

- Ongoing requirement for an immunosuppressive treatment

- Pregnant or breastfeeding

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Define Toxicities

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Richard T Penson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

September 2019

Related Keywords:

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Malignant Tumor of Peritoneum
  • Papillary Carcinoma of Uterus
  • Uterine Malignant Mixed Muellerian Tumour
  • Neoplasms
  • Carcinoma
  • Carcinoma, Papillary
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Uterine Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617