A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer
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ClinicalTrials.gov Identifier: NCT01711970 |
Recruitment Status :
Completed
First Posted : October 23, 2012
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Platinum Resistant Ovarian Cancer | Drug: Paclitaxel | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 38 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | May 3, 2017 |
Actual Study Completion Date : | May 3, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: VB-111 |
Drug: Paclitaxel |
- Define toxicities [ Time Frame: 2 years ]Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Prior treatment with an anti-angiogenic agent is not an exclusion criterion.
- 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.
Exclusion Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711970
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States |
Responsible Party: | Vascular Biogenics Ltd. operating as VBL Therapeutics |
ClinicalTrials.gov Identifier: | NCT01711970 |
Obsolete Identifiers: | NCT01801215 |
Other Study ID Numbers: |
VB-111-157 11-418 ( Other Identifier: DF/HCC ) |
First Posted: | October 23, 2012 Key Record Dates |
Last Update Posted: | April 24, 2020 |
Last Verified: | April 2020 |
Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |