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Adenocarcinoma of the ColonPhase 2NCT00397878

AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer

A Phase 2 study testing saracatinib and laboratory biomarker analysis in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial is studying how well AZD0530 works in treating patients with previously treated metastatic colon cancer or rectal cancer. AZD0530 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
saracatinib and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Nov 2006to Nov 2011
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

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic
  • Patients must have measurable disease, defined (per RECIST criteria) as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or >= 10 mm with spiral CT scan
  • Patients must have received one and only one prior chemotherapy regimen for metastatic colorectal cancer; patients may have received biologic therapy (e.g., bevacizumab) in combination with chemotherapy as part of their prior chemotherapy
  • ECOG performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
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  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< 1.5 x institutional ULN
  • AST(SGOT)/ALT(SGPT) =< 3.0 x institutional ULN
  • Creatinine within normal institutional limits OR estimated CrCl (Cockcroft-Gault) or 24 hr urine collection of >= 50 mL/min
  • The effects of AZD0530 on the developing human fetus at the recommended therapeutic dose are unknown; however, AZD0530 has been shown to cause gross fetal malformations and to negatively impact embryo fetal survival in rats; for this reason and because many tyrosine kinase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and up to 30 days following removal from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of child-bearing potential will have serum beta-Hcg levels drawn up to 7 days prior to receiving study treatment
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD0530, breastfeeding should be discontinued if the mother is treated with AZD0530
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study registration or those who have not recovered from treatment related adverse events > grade 1 (except for neuropathy [ies] which may be =< grade 2) due to agents administered more than 4 weeks earlier
  • Use of specifically prohibited CYP3A4-active agents or substances are not permitted during protocol treatment, and patients who must continue treatment with these agents are not eligible; prohibited drugs should be discontinued seven (7) days or 5 half-lives (whichever is the longer time period) prior to the administration of the first dose of AZD0530 and for 7 days or 5 half-lives (which ever is the longer time period) following discontinuation of AZD0530
  • Patients may not be receiving any other investigational agents
  • Patients with greater than +1 proteinuria on two consecutive readings taken no less than 24 hours apart are ineligible
  • Patients with QTc prolongation (defined as a QTc interval greater than or equal to 480 msecs) are ineligible
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring parenteral antibiotics at the time of registration), cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrhythmia or tachycardia (heart rate >= 100 beats per minute), poorly controlled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg)
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  • Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow AZD0530 tablets are excluded
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Pregnant women are excluded from this study because AZD0530 has the potential for teratogenic or abortifacient effects as shown by the gross fetal malformation and effects on embryofetal survival seen in reproductive toxicity studies in the rat
  • Patients with a history of another primary malignancy within the last 5 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
  • Patient who are known to be HIV-positive are ineligible because of the potential for pharmacokinetic interactions with AZD0530 and antiretroviral therapy (HAART)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Study of AZD0530 (NSC 735464) in Patients With Previously Treated Metastatic Colorectal Cancer

This phase II trial is studying how well AZD0530 works in treating patients with previously treated metastatic colon cancer or rectal cancer. AZD0530 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the progression-free survival (PFS) at 4 months in metastatic colorectal carcinoma patients receiving daily doses of AZD0530.

SECONDARY OBJECTIVES:

  1. Evaluate the objective response rate (RR) and overall survival (OS) of patients with metastatic colorectal cancer who are treated with AZD0530.

II. In patients who consent, both blood and tissue samples will be collected for laboratory correlates. Assess in a preliminary manner the association between correlative markers and the potential downstream effects of AZD0530 on IL-8, VEGF, specific Src-regulated markers in focal adhesions, adherens junctions, and angiogenesis on clinical outcome in pre- and post-treatment tumor samples.

OUTLINE:

Patients receive oral AZD0530 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Being tested
saracatinib, laboratory biomarker analysis
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • saracatinibDrug

    Also called AZD0530

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00397878
Study groupRoleWhat they receive
Treatment (saracatinib)ExperimentalPatients receive oral AZD0530 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: saracatinib; Other: laboratory biomarker analysis

What is being measured

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

  1. Median Progression Free Survival (PFS)

    Time period of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.

    Measured: Time from start of treatment to time of progression, up to 4 months

Secondary outcomes (2)

  1. Overall Survival

    Number of participants who survived up to 5 years

    Measured: Up to 5 years

  2. Time to Progression

    Number of participants who progressed on treatment within less than or equal to 2 cycles (cycle=28 days; within 54 days PD).

    Measured: within 54 days

Timeline

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

  1. First posted10 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionNov 2011
  4. Study completionNov 2011

Why it stopped: The study was terminated after all enrolled participants progressed.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00397878
Sponsor's protocol ID
NCI-2013-00067
Other IDs
NCI-2013-00067, CDR0000512970, MDA-2005-0977, NCI-7569, 2005-0977, 7565, N01CM62202, P30CA016672
Status last verified
Jul 2019
First submitted
9 Nov 2006
Last updated
20 Aug 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing saracatinib and laboratory biomarker analysis in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 1 site 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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 6 Feb 2014). 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?

Median Progression Free Survival (PFS) (time frame: Time from start of treatment to time of progression, up to 4 months). 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 NCT00397878.

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 20 Aug 2019.

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