Ovarian CancerPhase 1/2NCT00826150

Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer

A Phase 1/2 study testing BC-819 in people with Ovarian Cancer, run by Anchiano Therapeutics Israel Ltd. at 4 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer, or primary peritoneal carcinoma Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: BC-819
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 4 sitesIsrael
Study dates: Jun 2009to Feb 2012
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Provide written informed consent and be at least 18 years of age.
Have histopathologically documented epithelial ovarian carcinoma or primary peritoneal carcinoma with evidence of ascites.
Have either a) platinum-refractory disease (i.e. persistent disease following completion of platinum-based primary chemotherapy) and have failed at least primary platinum-based chemotherapy; or b) platinum-resistant recurrent disease and have failed at least one regimen of second line chemotherapy.
Be able to tolerate placement of IP catheter.
Be at least 2 weeks from last treatment to allow recovery from prior toxicity but in the judgment of the investigator with sufficient time to ensure that the effects of prior treatments will not confound safety evaluations.
Have a Karnofsky performance status score of ≥ 70%.

Show all 13Show fewer

Not be of child-bearing potential.
Have a life expectancy of ≥ 3 months.
Have serum creatinine < 2.0 mg/dL, total bilirubin less than the institution's 3x upper limit of normal (ULN); AST and ALT <= 2.5 x ULN,total albumin ≥ 2.5 g/dL, PT, PTT, and PT/INR within normal limits, absolute neutrophil count (ANC) > 1,500 x 103 cells/mL, platelets ≥ 100,000/mL, and hemoglobin ≥ 10 mg/dL.
Have a biopsy specimen or an ascites fluid that is positive for H19 expression.
Have screening procedures completed within 6-weeks before starting treatment.
No significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina or congestive heart failure.
- No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol.

Who cannot join

Have evidence of extra abdominal disease with the exception of isolated small nodules (e.g., liver or pulmonary nodules) that are not causing symptoms.
Have known brain metastases.
Have known HIV infection.
Have known active viral or bacterial infections.
Have presence of any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol or follow up schedule.
Have a medical condition contraindicated for laparotomy, laparoscopy, or surgery.
Have significant bowel involvement denoted by persistent grade 3 vomiting (≥6 episodes in 24 hrs; IV fluids, or total parenteral nutrition (TPN) indicated ≥24 hrs) after removal of ascites, inability to tolerate oral diet or medications, requirement for total parenteral nutrition, or recent (past six weeks) episode of bowel obstruction.
Have a history of coagulopathy.

Trial locations and contacts

4 sites in 1 country.

Israel4 sites

The Edith Wolfson Medical Center
Holon
Hadassah University Hospital
Jerusalem
Meir Hospital
Kfar Saba
Sheba Medical Center
Tel HaShomer

Other trials in Israel

About this study

Official title: Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer

Read the detailed description

This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma designed to determine the tolerability, safety, quality of life, PK, and preliminary efficacy of DTA-H19 administered intraperitoneally(IP).

Primary Objective: The primary objectives of this study are:

To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
To identify any dose limiting toxicities (DLTs).

Secondary Objectives: Secondary objectives of this study are:

To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;
To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.
To determine the overall survival distribution.

Conditions: Ovarian Cancer
Being tested: BC-819
Keywords: ovarian cancer, H19 gene, plasmid, inodiftagene vixteplasmid
Medical subject headings: Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BC-819Biological
Also called DTA-H19
Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

Study groups in NCT00826150
Study group	Role	What they receive
BC-819	Experimental	BC-819 60, 120 and 240 mg IP administration Receives: Biological: BC-819

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose-Limiting Toxicities
A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.
Measured: 8 weeks

Secondary outcomes (8)

Overall Survival in ITT Population
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
Measured: 17.5 months
Solid Tumor Response
If measurable disease was present, then the response of each marker lesion was evaluated separately and rated for response according to RECIST criteria for solid tumors.
Complete Response: Disappearance of the target lesion. Partial Response: At least a 30% decrease in the longest diameter of the target lesion.
Stable Disease: No sufficient shrinkage to qualify for partial response, or sufficient increase to qualify for progressive disease.
Progressive Disease: At least a 20% increase in the longest diameter of the target lesion.
Measured: 6 weeks
Systemic BC-819 Pharmacokinetics (PK) by Treatment - T1/2 (Hours)
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Measured: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) - Maximum Observed Plasma Concentration (Cmax)
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Measured: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - Tmax (Hours)
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Measured: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUClast
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Measured: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUCinf
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Measured: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Overall Survival in PP
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
Measured: 17.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Feb 2012

First posted21 Jan 2009 (estimated)
Study startJun 2009
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00826150
Sponsor's protocol ID: BC-08-01
Status last verified: May 2019
First submitted: 18 Jan 2009
Last updated: 13 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer
ClinicalTrials.gov ID: NCT00826150
Acronym / sponsor ID: BC-08-01
Conditions: Ovarian Cancer
Keywords: ovarian cancer, H19 gene, plasmid, inodiftagene vixteplasmid
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Anchiano Therapeutics Israel Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 21 Jan 2009 (estimated)
Results: Posted 13 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective: The primary objectives of this study are:

To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
To identify any dose limiting toxicities (DLTs).

Secondary Objectives: Secondary objectives of this study are:

To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;
To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.
To determine the overall survival distribution.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BC-819	Experimental	Biological: BC-819BC-819 60, 120 and 240 mg IP administration

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Provide written informed consent and be at least 18 years of age.
Have histopathologically documented epithelial ovarian carcinoma or primary peritoneal carcinoma with evidence of ascites.
Have either a) platinum-refractory disease (i.e. persistent disease following completion of platinum-based primary chemotherapy) and have failed at least primary platinum-based chemotherapy; or b) platinum-resistant recurrent disease and have failed at least one regimen of second line chemotherapy.
Be able to tolerate placement of IP catheter.
Be at least 2 weeks from last treatment to allow recovery from prior toxicity but in the judgment of the investigator with sufficient time to ensure that the effects of prior treatments will not confound safety evaluations.

Key exclusion criteria (8 listed)

Have evidence of extra abdominal disease with the exception of isolated small nodules (e.g., liver or pulmonary nodules) that are not causing symptoms.
Have known brain metastases.
Have known HIV infection.
Have known active viral or bacterial infections.
Have presence of any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol or follow up schedule.

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
BC-819Also: DTA-H19Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.	Biological	BC-819

Primary outcome

Number of Participants With Dose-Limiting Toxicities
Time frame: 8 weeks
A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.

8 secondary outcomes

Overall Survival in ITT Population
Time frame: 17.5 months
Solid Tumor Response
Time frame: 6 weeks
Systemic BC-819 Pharmacokinetics (PK) by Treatment - T1/2 (Hours)
Time frame: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) - Maximum Observed Plasma Concentration (Cmax)
Time frame: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - Tmax (Hours)
Time frame: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUClast
Time frame: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUCinf
Time frame: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Overall Survival in PP
Time frame: 17.5 months

Results and safety

Results posted to the registry on 13 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BC-819 60 mg IP	8	2
BC-819 120 mg IP	3	1
BC-819 240 mg IP	3	0

Primary outcome: Number of Participants With Dose-Limiting Toxicities

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	BC-819 60 mg IP n = 8	BC-819 120 mg IP n = 3	BC-819 240 mg IP n = 3
Value	0	0	0

Population analysed: Per Protocol data set (PP): 11 subjects who met the study inclusion and exclusion criteria, received at least one course of treatment of the investigational product and had a follow-up disease assessment comprised the PP set (5 subjects from the 60 mg cohort, 3 subjects from the 120 mg cohort; 3 subjects from the 240 mg cohort).

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BC-819 60 mg IP	6 of 8 (75%)	8 of 8 (100%)	3 of 8
BC-819 120 mg IP	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
BC-819 240 mg IP	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Tally Levy, M.D. principal investigator

The Edith Wolfson Medical Center

David Edelman, MD principal investigator

Hadassah University Hospital

Ami Fishman, MD principal investigator

Meir Medical Center

4 sites 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 BC-819 in people with Ovarian Cancer, run by Anchiano Therapeutics Israel Ltd. at 4 sites in Israel.

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 13 inclusion and 8 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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Israel. 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?

Yes. Results are posted in the registry (first posted 13 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Dose-Limiting Toxicities (time frame: 8 weeks). 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 NCT00826150.

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 13 Jun 2019.