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Carcinoma, Renal CellPhase 2NCT00073125

Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

A Phase 2 study testing ABT-510/Thrombospondin-1 mimetic in people with Carcinoma, Renal Cell, run by Abbott at 18 sites in 2 countries.

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

The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
ABT-510/Thrombospondin-1 mimetic
How many people
103 participants
Where
18 sitesin 2 countries
Study dates
May 2003to not given
Phase
Phase 2
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

  • A subject will be eligible for study participation if all of the following criteria are met:
  • The subject is at least 18 years of age.
  • The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amendable to curative resection.
  • The subject has not received prior therapy (anti-tumor radiotherapy, immunotherapy, chemotherapy, or investigational therapy) for metastatic renal cell carcinoma other than excision of primary tumor where appropriate. Local radiation for supportive reasons will be allowed; however, not within 28 days from Study Day 1.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1
  • The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
Show all 12Show fewer
  • The subject must have adequate bone marrow, renal, and hepatic function as follows:
  • Bone Marrow: White blood cell count (WBC) ≥ 3,000/mm3 (3.0 X 109/L); Platelets ≥ 100,000/mm3 (100 X 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)
  • Renal function: serum creatinine ≤ 2.0 mg/dL (0.81 mmol/L)
  • Hepatic function: AST and ALT ≤ 1.5 X ULN unless liver metastases are present, then AST and ALT ≤ 5.0 X ULN; LDH ≤ 1.5 X ULN; bilirubin ≤ 1.5 mg/dL (0.026 mmol/L) Corrected calculated calcium ≤ 10 mg/dL (2.5 mmol/L) Calculation = total calcium - 0.707 (albumin -3.4)Albumin ≥ 3.0 g/dL (0.45 mmol/L)
  • The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
  • The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Who cannot join

  • A subject will be ineligible for study participation if any of the following criteria are met:
  • The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
  • The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
  • The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding.
  • The subject exhibits evidence of clinically significant uncontrolled conditions(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
  • The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix uteri or Basal or squamous cell carcinoma of the skin

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States17 sites

  • Albany Regional Cancer Center

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Raleigh Hematology Oncology Clinic

    Cary, North Carolina, 27511

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • US Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Cancer Center

    Fort Worth, Texas, 66210

  • Texas Cancer Center

    Fort Worth, Texas, 76104

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas

  • Central indiana Cancer Center

    Indianapolis, Indiana, 46227

  • Kansas City Oncology and Hematology Group

    Kansas City, Missouri, 64111

  • UCLA School of Medicine

    Los Angeles, California, 90024

  • Clinical Trials and Research Associates

    Montebello, California, 90640

  • Kansas City Cancer Centers Southwest

    Overland Park, Kansas, 66210

  • Virginia G. Piper Cancer Center

    Scottsdale, Arizona, 85258

  • Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

Netherlands1 site

  • Academic Hospital Groningen

    Groningen

Other trials in Netherlands

About this study

Official title: A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma.

Being tested
ABT-510/Thrombospondin-1 mimetic
Keywords
Advanced histologically documented renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • ABT-510/Thrombospondin-1 mimeticDrug

What is being measured

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

  1. Progression free survival

    Measured: One year

Secondary outcomes (3)

  1. Response rate

    Measured: One year

  2. Overall survival

    Measured: One year

  3. Performance status

    Measured: One year

Timeline

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

  1. First posted18 Nov 2003 (estimated)
  2. Study startMay 2003

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00073125
Sponsor's protocol ID
M02-428
Status last verified
Aug 2007
First submitted
17 Nov 2003
Last updated
15 Aug 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-510/Thrombospondin-1 mimetic in people with Carcinoma, Renal Cell, run by Abbott at 18 sites in 2 countries.

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 6 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 15 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Netherlands. 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?

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?

Progression free survival (time frame: One year). 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 NCT00073125.

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 15 Aug 2007.

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