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CancerPhase 1NCT00582985

Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer

A Phase 1 study testing TRC105 chimeric anti-CD105 antibody in people with Cancer and Neoplasm Metastasis, run by Tracon Pharmaceuticals Inc. at 4 sites in United States.

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 being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Neoplasm Metastasis
What is being tested?
TRC105 chimeric anti-CD105 antibody
Type of treatment
Injection or infusion
How many people
51 participants
Where
4 sitesUnited States
Study dates
Dec 2007to Jun 2011
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has given informed consent.
  • The patient is willing and able to abide by the protocol.
  • The patient has cancer and curative therapy is unavailable.
  • The patient is at least 18 years old.
  • The patient has adequate ability to perform activities of daily living.
  • Significant toxicities from prior therapy must have recovered.
  • The patient has adequate organ function as assessed by laboratory test.

Who cannot join

  • The patient weighs more than 264 lbs.
  • The patient has a known allergy to gentamicin
  • The patient has had prior treatment with high-dose chemotherapy requiring stem cell rescue
  • The patient is currently on treatment on another therapeutic clinical trial or has received an investigational agent within 4 weeks prior to first dose with study drug
  • The patient has had prior surgery (including open biopsy), radiation therapy or systemic therapy within 4 weeks of starting the study treatment
  • The patient has hypertension > 160/90
Show all 16Show fewer
  • The patient has a history of CNS cancer
  • The patient has an unstable medical condition including, but not limited to, cardiac disease, history of stroke, active hepatitis, or significant pericardial, pleural or peritoneal effusion
  • The patient received recent thrombolytic or anticoagulant therapy
  • The patient has lung cancer with central chest lesions
  • The patient has had hemorrhage or unhealed wounds within 30 days of dosing
  • The patient has used systemic corticosteroids within 3 months of dosing
  • The patient has known HIV/AIDS
  • The patient has a history of hypersensitivity reaction to human or mouse antibody products
  • The patient is pregnant or breastfeeding.
  • The patient has a history of peptic ulcer disease or gastritis within 6 months of dosing, unless complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 30 days of dosing

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Study site

    Buffalo, New York, 14263

  • Study site

    Durham, North Carolina, 27705

  • Study site

    Santa Monica, California, 90404

  • Study site

    Scottsdale, Arizona, 85260

Other trials in United States

About this study

Official title: An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable

This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.

Read the detailed description

In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.

Being tested
TRC105 chimeric anti-CD105 antibody
Keywords
Tracon, CD105, Anti CD105, TRC105, Phase 1, Cancer, Monoclonal antibody, Solid Tumor
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

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

  • TRC105 chimeric anti-CD105 antibodyDrug

    TRC105 is a human/murine chimeric IgG1 antibody administered i.v. every two weeks (on days 1 and 15) or weekly (on days 1, 8, 15 and 22) of each 28 day cycle; until progression or unacceptable toxicity develops.

What is being measured

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

  1. Safety and Tolerability will be evaluated

    Measured: Through last patient last visit

  2. Dose Limiting Toxicities

    Measured: 28 day evaluation period

Secondary outcomes (2)

  1. Pharmacokinetics of TRC105 monoclonal antibody

    Measured: through last patient last visit

  2. Number of responses by tumor type

    Measured: through last patient last visit

Timeline

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

  1. First posted28 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00582985
Sponsor's protocol ID
105ST101
Status last verified
Mar 2012
First submitted
19 Dec 2007
Last updated
5 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • Seon BK, Haba A, Matsuno F, Takahashi N, Tsujie M, She X, Harada N, Uneda S, Tsujie T, Toi H, Tsai H, Haruta Y. Endoglin-targeted cancer therapy. Curr Drug Deliv. 2011 Jan;8(1):135-43. doi: 10.2174/156720111793663570.

    PubMed 21034418

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TRC105 chimeric anti-CD105 antibody in people with Cancer and Neoplasm Metastasis, run by Tracon Pharmaceuticals Inc. at 4 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 5 Mar 2012. 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 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?

Safety and Tolerability will be evaluated (time frame: Through last patient last visit). The study lists 2 primary outcomes in all. 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 NCT00582985, 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 5 Mar 2012.

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