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CarcinomaPhase 1/2NCT00557596

A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer

A Phase 1/2 study testing AEG35156 in people with Carcinoma and Pancreas, run by Aegera Therapeutics at 4 sites 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 is an open-label multicenter, phase 1-2 study. Following determination of the recommended AEG35156 dose in combination with gemcitabine in the initial Phase 1 part of this study, additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination first-line in advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Pancreas
What is being tested?
AEG35156
Type of treatment
Injection or infusion
How many people
48 participants
Where
4 sitesUnited States
Study dates
Sep 2007to Nov 2009
Phase
Phase 1/2
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

  • Patients with histologically or cytologically confirmed advanced pancreatic adenocarcinoma who are candidates for first-line gemcitabine therapy
  • Karnofsky performance >70%
  • One or more metastatic tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)
  • Life expectancy of at least 3 months
  • Age > 18 years
  • Signed, written IRB-approved informed consent
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  • A negative serum pregnancy test (if applicable)
  • Acceptable liver function:
  • Bilirubin < 1.5 times the institution's upper limit of normal
  • AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 2.5 times the institution's upper limit of normal
  • Acceptable renal function:
  • Serum creatinine within normal limits, OR calculated creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Acceptable hematologic status:
  • Granulocyte > 1500 cells/uL
  • Platelet count > 100,000 plt/uL
  • Hemoglobin > 9.0 g/dL
  • Acceptable coagulation status:
  • PT within normal limits
  • PTT within normal limits
  • For women of child-producing potential, the use of effective contraceptive methods during the study
  • Prior radiotherapy for local disease is allowed provided disease progression has been documented, and treatment completed at least 4 weeks prior to registration

Who cannot join

  • Prior chemotherapy for pancreatic cancer, except for 5-fluorouracil or gemcitabine given as a radiosensitizer
  • Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions.
  • Known bleeding diathesis or concurrent treatment with anticoagulants except patients on non-therapeutic line maintenance coumadin
  • Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Men who are unwilling to use acceptable forms of birth control when engaging in sexual contact with women of child bearing potential
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
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  • Known infection with HIV, hepatitis B, or hepatitis C
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Patients who are currently receiving any other investigational agent. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
  • Unwillingness or inability to comply with procedures required in this protocol

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Scottsdale Healthcare - SHEA

    Scottsdale, Arizona, 85258

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Arizona Cancer Center - University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: A Phase 1-2, Multicenter, Open-Label Study of The X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer

This is an open-label multicenter, phase 1-2 study. Following determination of the recommended AEG35156 dose in combination with gemcitabine in the initial Phase 1 part of this study, additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination first-line in advanced pancreatic cancer.

Read the detailed description

Apoptotic induction in cancer cells is a sought after therapeutic goal. Most successful anticancer agents activate apoptosis pathways in the cancers they treat. Apoptotic pathways in cells appear to converge on a single family of enzymes, the caspases, which are proteases that dismantle the cell in an orderly, non-inflammatory fashion, resulting in cell death. The X-linked Inhibitor of Apoptosis (XIAP) is the only known cellular inhibitor of caspases, its over expression thereby blocks the principal means of apoptosis. A wide range of evidence indicates that cellular overexpression of members of the IAP family is a fundamental means by which many cancer cells evade death, even in the presence of strong extrinsic (death receptor-mediated) and intrinsic (mitochondria-mediated) apoptotic cues. The inhibition of cellular XIAP activity, specifically in cancer cells under stress and primed for apoptosis by chemotherapeutic agents, is viewed as a powerful means of tipping the balance towards cell death. In particular, XIAP has been shown to be overexpressed in pancreatic cancer and to play an important role in gemcitabine resistance. AEG35156 is a second generation antisense which targets XIAP mRNA to lower XIAP levels and the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and chemotherapy. AEG35156 may thus enhance the anticancer activity of gemcitabine in patients with advanced pancreatic cancer.

Conditions
Carcinoma, Pancreas
Being tested
AEG35156
Keywords
Pancreatic, antisense, oligonucleotide, gemcitabine
Medical subject headings
Carcinoma

What participants receive

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

  • AEG35156Drug

    AEG35156 will be given as a 2-hour intravenous infusion once weekly, only on weeks when gemcitabine is administered, with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1

What is being measured

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

  1. To determine the recommended dose of AEG35156 when used in combination with gemcitabine and the change in response rate of gemcitabine in patients

    Measured: 1 year

Secondary outcomes (2)

  1. To determine progression-free survival.

    Measured: 2 years

  2. To establish the pharmacokinetics of AEG35156 and gemcitabine when used in combination.

    Measured: 1 year

Timeline

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

  1. First posted14 Nov 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionNov 2009 (estimated)
  4. Study completionNov 2009 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00557596
Sponsor's protocol ID
AEG35156-201
Status last verified
Nov 2009
First submitted
13 Nov 2007
Last updated
1 Dec 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AEG35156 in people with Carcinoma and Pancreas, run by Aegera Therapeutics 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 21 inclusion and 10 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 1 Dec 2009. 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 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?

The study was stopped early. Results are not available in the source record.

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?

To determine the recommended dose of AEG35156 when used in combination with gemcitabine and the change in response rate of gemcitabine in patients (time frame: 1 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 NCT00557596.

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 1 Dec 2009.

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