Recurrent Ovarian CancerPhase 2NCT01381861
Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
A Phase 2 study testing Carotuximab (TRC105) in people with Recurrent Ovarian Cancer and Fallopian Tube Carcinoma, run by Tracon Pharmaceuticals Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- What is being tested?
- Carotuximab (TRC105)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2011to Dec 2013
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Measurable disease per RECIST 1.1
- At least one "target lesion" per RECIST 1.1
- Patients must have GOG Performance Status of 0 or 1
- Patients must have a life expectancy of ≥ 3 months
- Resolution of all acute toxic effects of prior therapy
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- Free of active infection requiring antibiotics
- Must have had one prior platinum-based chemotherapeutic regimen for management of primary disease
- Patients could have received one additional cytotoxic regimen for management of recurrent disease
- Prior therapy directed at the malignant tumor, including hormonal and immunologic agents, must be discontinued at least three weeks prior to registration. Continuation of hormone replacement therapy is permitted.
- Adequate bone marrow function, renal function, hepatic function, neurologic function, blood coagulation parameters
- Negative serum pregnancy test and effective form of contraception for patients of childbearing potential
Who cannot join
- Previous treatment with TRC105
- Current treatment on another therapeutic clinical trial
- Receipt of an investigational agent within 28 days of starting study treatment
- Serious, non-healing wounds, ulcers, or bone fractures.
- Active bleeding or pathologic conditions that carry a high risk of bleeding
- Patients with tumor involving major vessels or transmural bowel wall involvement by tumor
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- Use of thrombolytic or anticoagulant agents (except heparin to maintain i.v. catheters) within 10 days prior to the first dose of TRC105
- History of deep venous thrombosis (DVT)(except patients who have received adequate anticoagulation are eligible, and may continue on anticoagulation if appropriate)
- History of peptic ulcer disease or erosive gastritis within the past 6 months
- Known active viral or nonviral hepatitis
- History or evidence of CNS disease
- Clinically significant cardiovascular disease
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human, chimeric, or humanized antibodies
- Pregnant or nursing
- Under the age of 18
- Patients with or with anticipation of invasive procedures including major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment with TRC105
- History of other invasive malignancies, except non-melanoma skin cancer and other cancers that have been treated with no evidence of disease within the last 3 years
- History of primary endometrial cancer diagnosed within the last 5 years, unless all of the following conditions are met: Stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed > 3 years prior to registration, and patient remains free of recurrent or metastatic disease
- Prior radiotherapy to any portion of the abdominal cavity or pelvis
- Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
MD Anderson Cancer Center
Houston, Texas, 77230
Indiana University-Bren and Melvin Simon Cancer Center
Indianapolis, Indiana, 46202
University of California, San Diego
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
About this study
Official title: A Phase 2 Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Read the detailed description
Angiogenesis plays a central role in the progression of epithelial ovarian cancer. In mouse models, VEGF-inhibitors diminish ovarian tumor growth, metastasis and malignant ascites formation. Independent Phase 2 trials have demonstrated single-agent activity for bevacizumab in recurrent ovarian cancer, and randomized controlled Phase 3 trials are ongoing in the first-line setting (GOG 0218 and ICON-7) and for recurrent disease (GOG 0213, OCEANS).
TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on vascular endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. In a Phase 1 study of advanced solid tumors, TRC105 therapy caused a global reduction in angiogenic biomarkers and reduced tumor burden at doses that were well-tolerated. We hypothesize that TRC105 will have single-agent activity in recurrent ovarian cancer. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibitors which could represent a major advance in ovarian cancer therapy.
- Being tested
- Carotuximab (TRC105)
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotuximab (TRC105)Biological
Also called TRC105, NSC#754227
Carotuximab (TRC105) 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Carotuximab (TRC105) alone | Experimental | Single arm, open label Carotuximab (TRC105) alone therapy dosed at 10 mg/kg administered intravenously over 1 to 4 hours on days 1, 8, 15 and 22 of each 28 day cycle Receives: Biological: Carotuximab (TRC105) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival Rate After 6 Months of Treatment on Study
Number of patients ongoing within the study who have not progressed after 6 months of treatment
Measured: 6 months
Proportion of Patients Who Have Objective Tumor Response
Proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1
Measured: Every 2 cycles
Adverse Events
Frequency of adverse events as assessed by NCI CTCAE (Version 4.0)
Measured: 28 days
Secondary outcomes (5)
CA-125 Response Rate
CA-125 response rate by GCIG criteria
Measured: Every 2 cycles
Serum Concentrations of TRC105
Median peak and trough concentration of TRC105 by ELISA in ug/mL
Measured: Cycle 1 Day 15
TRC105 Immunogenicity
TRC105 Anti-Drug Antibody (ADA) Immunogenicity by ELISA
Measured: 1 year
Severity of Adverse Events
Severity of adverse events by NCI CTCAE
Measured: 28 days post last dose of TRC105
Overall Survival
Median overall survival
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 posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2012
- Study completionDec 2013
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 Recurrent 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles P Theuer, MD, Study director, TRACON Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381861
- Sponsor's protocol ID
- 105OC201
- Status last verified
- Feb 2019
- First submitted
- 21 Jun 2011
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT01381861
- Acronym / sponsor ID
- 105OC201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tracon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Detailed description
Angiogenesis plays a central role in the progression of epithelial ovarian cancer. In mouse models, VEGF-inhibitors diminish ovarian tumor growth, metastasis and malignant ascites formation. Independent Phase 2 trials have demonstrated single-agent activity for bevacizumab in recurrent ovarian cancer, and randomized controlled Phase 3 trials are ongoing in the first-line setting (GOG 0218 and ICON-7) and for recurrent disease (GOG 0213, OCEANS).
TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on vascular endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. In a Phase 1 study of advanced solid tumors, TRC105 therapy caused a global reduction in angiogenic biomarkers and reduced tumor burden at doses that were well-tolerated. We hypothesize that TRC105 will have single-agent activity in recurrent ovarian cancer. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibitors which could represent a major advance in ovarian cancer therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotuximab (TRC105) alone | Experimental | Biological: Carotuximab (TRC105)Single arm, open label Carotuximab (TRC105) alone therapy dosed at 10 mg/kg administered intravenously over 1 to 4 hours on days 1, 8, 15 and 22 of each 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Measurable disease per RECIST 1.1
- At least one "target lesion" per RECIST 1.1
- Patients must have GOG Performance Status of 0 or 1
- Patients must have a life expectancy of ≥ 3 months
Key exclusion criteria (21 listed)
- Previous treatment with TRC105
- Current treatment on another therapeutic clinical trial
- Receipt of an investigational agent within 28 days of starting study treatment
- Serious, non-healing wounds, ulcers, or bone fractures.
- Active bleeding or pathologic conditions that carry a high risk of bleeding
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 |
|---|---|---|
| Carotuximab (TRC105)Also: TRC105, NSC#754227Carotuximab (TRC105) 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle | Biological | Carotuximab (TRC105) alone |
Primary outcome
Progression-free Survival Rate After 6 Months of Treatment on Study
Time frame: 6 months
Number of patients ongoing within the study who have not progressed after 6 months of treatment
Proportion of Patients Who Have Objective Tumor Response
Time frame: Every 2 cycles
Proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1
Adverse Events
Time frame: 28 days
Frequency of adverse events as assessed by NCI CTCAE (Version 4.0)
5 secondary outcomes
CA-125 Response Rate
Time frame: Every 2 cycles
Serum Concentrations of TRC105
Time frame: Cycle 1 Day 15
TRC105 Immunogenicity
Time frame: 1 year
Severity of Adverse Events
Time frame: 28 days post last dose of TRC105
Overall Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
Charles P Theuer, MD study director
TRACON Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carotuximab (TRC105) in people with Recurrent Ovarian Cancer and Fallopian Tube Carcinoma, run by Tracon Pharmaceuticals Inc. at 7 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 12 inclusion and 21 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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 5 Mar 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?
Progression-free Survival Rate After 6 Months of Treatment on Study (time frame: 6 months). The study lists 3 primary outcomes in all. 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 5 Mar 2019.