Metastatic Breast CancerPhase 1/2TRC105NCT01326481
Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer
A Phase 1/2 study testing TRC105 and Capecitabine in people with Metastatic Breast Cancer, run by Tracon Pharmaceuticals Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- TRC105 and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Dec 2014
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)
- Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)
- Measurable disease by RECIST 1.1 criteria (Part 2 only)
- Willing and able to consent for self to participate in study
- Progressive or recurrent disease after prior systemic chemotherapy regimen
- Age ≥ 18 years
Show all 9Show fewer
- ECOG performance status of 0 or 1
- Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)
- Adequate organ function
Who cannot join
- Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.
- Prior treatment with TRC105
- History of hypersensitivity reaction to antimetabolite therapy
- Receipt of an investigational agent within 28 days of starting study treatment
- Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment
- Minor surgical procedures within 14 days prior to first dose of TRC105
Show all 20Show fewer
- History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
- Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months
- Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy
- Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia
- Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105
- Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last month
- Hemorrhage within 28 days of starting study treatment
- Unhealed wounds within 28 days of starting study treatment
- History of peptic ulcer disease or gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Known active viral or nonviral hepatitis
- History of hypersensitivity reaction to human or mouse antibody products
- Lung cancer with central chest lesions
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Roswell Park Cancer Institute
Buffalo, New York, 14201
About this study
Official title: An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer
The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.
Read the detailed description
All patients were required to sign a consent form prior to undertaking any study-related procedures. Prospective patients were screened to determine if they qualified for the study within 28 days of enrollment. Patients who qualified received TRC105 i.v. over 1 to 4 hours on Day 1, Day 4, Day 8 and Day 15 of the initial 21-day cycle and Day 1, Day 8 and Day 15 of every subsequent 21-day cycle in combination with 1000 mg/m2 capecitabine BID for 14 days of each 21-day cycle. Those who tolerated TRC105 without any infusion reactions were eligible for reduced infusion durations. After 3 cycles of treatment, patients who demonstrated a response of complete response (CR), partial response (PR) or stable disease (SD) were eligible for additional treatment for up to six months (9 total cycles). Upon discussion with TRACON, patients judged by the Principal Investigator to be benefiting from treatment were able to continue treatment on this protocol beyond six months.
Toxicities were graded according to the NCI CTCAE Version 4.0. Patients who exited the study for reasons other than drug-related toxicity prior to completion of the first 21-day cycle were replaced. Intra-patient dose escalation was not allowed.
- Conditions
- Metastatic Breast Cancer
- Being tested
- TRC105, Capecitabine
- Keywords
- TRC105, Breast Cancer, CD105, Endoglin, TRACON Pharma, Roswell Park Cancer Institute, Department of Defense
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRC105Drug
Also called carotuximab
IV
CapecitabineDrug
Also called xeloda
oral
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | All patients received TRC105 + capecitabine Receives: Drug: TRC105; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine
Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.
Measured: 1.5 years
Secondary outcomes (3)
TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D
Mean trough concentration for patients dosed at 10 mg/kg at cycle 2 day 1
Measured: Cycle 2 day 1 (3 weeks)
Number of Patients With Positive Immune Response to TRC105
Serial blood samples will be tested for anti-drug antibody (ADA) immune response to TRC105. Patients who are positive at baseline (prior to receiving TRC105) are excluded from analysis.
Measured: 1.5 years
Number of Patients With Objective Response According to RECIST 1.1
The best response according to RECIST 1.1 for each patient with measurable disease who received at least one dose of study drug will be listed by cohort and tumor type
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2014
- Study completionDec 2014
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 Metastatic Breast 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roswell Park Cancer Institute, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Charles Theuer, MD PhD, Study chair, Tracon Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326481
- Sponsor's protocol ID
- 105BC102
- Acronym
- TRC105
- Status last verified
- Feb 2019
- First submitted
- 25 Mar 2011
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01326481
- Acronym / sponsor ID
- TRC105 / 105BC102
- Conditions
- Metastatic Breast Cancer
- Keywords
- TRC105, Breast Cancer, CD105, Endoglin, TRACON Pharma, Roswell Park Cancer Institute, Department of Defense
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Tracon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roswell Park Cancer Institute, United States Department of Defense
- Study start
- Jun 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Posted 26 Feb 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 determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.
Detailed description
All patients were required to sign a consent form prior to undertaking any study-related procedures. Prospective patients were screened to determine if they qualified for the study within 28 days of enrollment. Patients who qualified received TRC105 i.v. over 1 to 4 hours on Day 1, Day 4, Day 8 and Day 15 of the initial 21-day cycle and Day 1, Day 8 and Day 15 of every subsequent 21-day cycle in combination with 1000 mg/m2 capecitabine BID for 14 days of each 21-day cycle. Those who tolerated TRC105 without any infusion reactions were eligible for reduced infusion durations. After 3 cycles of treatment, patients who demonstrated a response of complete response (CR), partial response (PR) or stable disease (SD) were eligible for additional treatment for up to six months (9 total cycles). Upon discussion with TRACON, patients judged by the Principal Investigator to be benefiting from treatment were able to continue treatment on this protocol beyond six months.
Toxicities were graded according to the NCI CTCAE Version 4.0. Patients who exited the study for reasons other than drug-related toxicity prior to completion of the first 21-day cycle were replaced. Intra-patient dose escalation was not allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Drug: TRC105, Drug: CapecitabineAll patients received TRC105 + capecitabine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)
- Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)
- Measurable disease by RECIST 1.1 criteria (Part 2 only)
- Willing and able to consent for self to participate in study
- Progressive or recurrent disease after prior systemic chemotherapy regimen
Key exclusion criteria (20 listed)
- Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.
- Prior treatment with TRC105
- History of hypersensitivity reaction to antimetabolite therapy
- Receipt of an investigational agent within 28 days of starting study treatment
- Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment
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 |
|---|---|---|
| TRC105Also: carotuximabIV | Drug | Single |
| CapecitabineAlso: xelodaoral | Drug | Single |
Primary outcome
Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine
Time frame: 1.5 years
Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.
3 secondary outcomes
TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D
Time frame: Cycle 2 day 1 (3 weeks)
Number of Patients With Positive Immune Response to TRC105
Time frame: 1.5 years
Number of Patients With Objective Response According to RECIST 1.1
Time frame: 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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 Theuer, MD PhD study chair
Tracon Pharmaceuticals Inc.
2 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 TRC105 and Capecitabine in people with Metastatic Breast Cancer, run by Tracon Pharmaceuticals Inc. at 2 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 9 inclusion and 20 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 18 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 2 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 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 26 Feb 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?
Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine (time frame: 1.5 years). 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 18 Mar 2019.