Platinum Resistant Ovarian CancerPhase 1/2NCT01711970
A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer
A Phase 1/2 study testing Paclitaxel in people with Platinum Resistant Ovarian Cancer, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum Resistant Ovarian Cancer
- What is being tested?
- Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 3 May 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts
About this study
Official title: A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer
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.
- Conditions
- Platinum Resistant Ovarian Cancer
- Being tested
- Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| VB-111 | Experimental | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define toxicities
Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startNov 2012
- Primary completion3 May 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platinum Resistant Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711970
- Sponsor's protocol ID
- VB-111-157
- Other IDs
- 11-418
- Status last verified
- Apr 2020
- First submitted
- 18 Oct 2012
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32265057
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer
- ClinicalTrials.gov ID
- NCT01711970
- Acronym / sponsor ID
- VB-111-157
- Conditions
- Platinum Resistant Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VB-111 | Experimental | Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel | Drug | VB-111 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 32265057Arend 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paclitaxel in people with Platinum Resistant Ovarian Cancer, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define toxicities (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01711970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.