Relapsed Epithelial Ovarian CancerPhase 1NCT01940172
Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer
A Phase 1 study testing Birinapant and Conatumumab in people with Relapsed Epithelial Ovarian Cancer and Relapsed Primary Peritoneal Cancer, run by TetraLogic Pharmaceuticals at 9 sites in United States.
Trial summary
This is a dose escalation study in female subjects with relapsed ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Approximately 30 to 40 subjects will be administered a combination of conatumumab and birinapant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Relapsed Epithelial Ovarian Cancer, Relapsed Primary Peritoneal Cancer, Relapsed Fallopian Tube Cancer
- What is being tested?
- Birinapant and Conatumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 1
- 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
- Is a women who is at least 18 years of age.
- Has a negative serum pregnancy test at screening for women of childbearing potential.
- Pathologically confirmed ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) may have had a maximum of 3 prior systemic chemotherapy regimens (excluding hormonal therapies and investigational agents).
- Has a performance status of 0 or 1 by the Eastern Cooperative Oncology Group (ECOG) scale.
- Has a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria AND meet Gynecologic Cancer InterGroup (GCIG) CA 125 criteria.
- Has a life expectancy of at least 3 months.
- Has adequate liver, renal, pancreatic, coagulation and bone marrow function.
Who cannot join
- Has symptomatic or uncontrolled brain metastases requiring current treatment (<8 weeks from last cranial radiation treatment or <4 weeks from last steroid treatment).
- Has known intolerance to any of the study drugs or any of their excipients.
- Has known or suspected diagnosis of human immunodeficiency virus (HIV) or chronic active Hepatitis B or C.
- Has uncontrolled hypertension defined as blood pressure >160/100 mmHg without medication, or not controlled despite medications.
- Has received systemic chemotherapy, hormonal therapy, immunotherapy, anti-tumor necrosis factor (TNF) therapies, experimental or approved anticancer proteins/antibodies therapy
- ≤28 days before enrollment.
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- Has impaired cardiac function or clinically significant cardiac disease including the following:
- New York Heart Association Grade III or IV congestive heart failure.
- Myocardial infarction within the last 12 months prior to dosing with birinapant.
- Has a QT interval corrected for heart rate (QTcB) >480 msec (including subjects on medication). Subjects with a ventricular pacemaker for whom QT interval is not measurable may be eligible.
- Has a lack of recovery of prior adverse non-hematological events to Grade ≤1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.
- Has any concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation, render the subject at excessive risk (including excessive risks due to the toxicity profile of the planned combination chemotherapeutic regimen), or limit the subject's compliance with the protocol's required evaluations.
- Has a prior history of cranial nerve palsy.
- Has autoimmune diseases or inflammatory diseases, for example, active rheumatoid arthritis, active inflammatory bowel disease or any chronic inflammatory conditions.
- Has pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, neuroendocrine histology, clear cell or mucinous histology or subjects with borderline ovarian cancer.
- Requires concomitant chronic use of anti-TNF therapies, corticosteroids or nonsteroidal anti- inflammatory drugs (NSAIDS). Intermittent use (7 or fewer days per 14 days) of corticosteroids as pre-medications is allowed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
TetraLogic Research Site
Boston, Massachusetts, 02114
TetraLogic Research Facility
Dallas, Texas, 75201
TetraLogic Research Site
Durham, North Carolina, 27710
TetraLogic Research Site
Fairway, Kansas, 66205
TetraLogic research site
Fresno, California, 39720
TetraLogic Research Site
Nashville, Tennessee, 37203
TetraLogic Research Site
Philadelphia, Pennsylvania, 19107
TetraLogic Research Site
Philadelphia, Pennsylvania, 19111
TetraLogic Research Site
San Luis Obispo, California, 93401
About this study
Official title: A Phase 1b, Open-label, Non-randomized Multicenter Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
This is a dose escalation study in female subjects with relapsed ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Approximately 30 to 40 subjects will be administered a combination of conatumumab and birinapant.
In the initial dose-escalation stage of the study, adult female subjects will receive conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to determine the MTD of birinapant when administered with a fixed dose of conatumumab.
In safety expansion stage, adult female subjects will receive conatumumab in combination with birinapant at the MTD of the combination.
- Conditions
- Relapsed Epithelial Ovarian Cancer, Relapsed Primary Peritoneal Cancer, Relapsed Fallopian Tube Cancer
- Being tested
- Birinapant, Conatumumab
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BirinapantDrug
Also called TL32711
Dose Escalation:
Dose Level (1) - 13 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (2) - 13 mg/m2 (twice weekly for 4 weeks );
ConatumumabDrug
10 mg/kg IV on Day 1 and 15 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Birinapant with Conatumumab | Experimental | Not described Receives: Drug: Birinapant; Drug: Conatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerated Dose (MTD)
Measured: 28 Days
Secondary outcomes (1)
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Epithelial 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- TetraLogic Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940172
- Sponsor's protocol ID
- TL32711-POC-0090-PTL
- Status last verified
- Jan 2016
- First submitted
- 6 Sep 2013
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Non-randomized Multicenter Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT01940172
- Acronym / sponsor ID
- TL32711-POC-0090-PTL
- Conditions
- Relapsed Epithelial Ovarian Cancer, Relapsed Primary Peritoneal Cancer, Relapsed Fallopian Tube Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- TetraLogic PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Sep 2013 (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 dose escalation study in female subjects with relapsed ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Approximately 30 to 40 subjects will be administered a combination of conatumumab and birinapant.
In the initial dose-escalation stage of the study, adult female subjects will receive conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to determine the MTD of birinapant when administered with a fixed dose of conatumumab.
In safety expansion stage, adult female subjects will receive conatumumab in combination with birinapant at the MTD of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Birinapant with Conatumumab | Experimental | Drug: Birinapant, Drug: Conatumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is a women who is at least 18 years of age.
- Has a negative serum pregnancy test at screening for women of childbearing potential.
- Pathologically confirmed ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) may have had a maximum of 3 prior systemic chemotherapy regimens (excluding hormonal therapies and investigational agents).
- Has a performance status of 0 or 1 by the Eastern Cooperative Oncology Group (ECOG) scale.
- Has a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria AND meet Gynecologic Cancer InterGroup (GCIG) CA 125 criteria.
Key exclusion criteria (16 listed)
- Has symptomatic or uncontrolled brain metastases requiring current treatment (<8 weeks from last cranial radiation treatment or <4 weeks from last steroid treatment).
- Has known intolerance to any of the study drugs or any of their excipients.
- Has known or suspected diagnosis of human immunodeficiency virus (HIV) or chronic active Hepatitis B or C.
- Has uncontrolled hypertension defined as blood pressure >160/100 mmHg without medication, or not controlled despite medications.
- Has received systemic chemotherapy, hormonal therapy, immunotherapy, anti-tumor necrosis factor (TNF) therapies, experimental or approved anticancer proteins/antibodies therapy
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 |
|---|---|---|
| BirinapantAlso: TL32711Dose Escalation: Dose Level (1) - 13 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (2) - 13 mg/m2 (twice weekly for 4 weeks ); | Drug | Birinapant with Conatumumab |
| Conatumumab10 mg/kg IV on Day 1 and 15 of each cycle | Drug | Birinapant with Conatumumab |
Primary outcome
Determination of Maximum Tolerated Dose (MTD)
Time frame: 28 Days
1 secondary outcome
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).
Time frame: Up to 4 months
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 14 Jan 2016.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Birinapant and Conatumumab in people with Relapsed Epithelial Ovarian Cancer and Relapsed Primary Peritoneal Cancer, run by TetraLogic Pharmaceuticals at 9 sites 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 7 inclusion and 16 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 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 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.
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?
Determination of Maximum Tolerated Dose (MTD) (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2016.