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Advanced Hepatocellular CarcinomaPhase 1/2NCT00882869

XIAP Antisense AEG35156 in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

A Phase 1/2 study testing AEG35156 antisense IV infusion and Sorafenib in people with Advanced Hepatocellular Carcinoma, run by Aegera Therapeutics at 3 sites in China.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
AEG35156 antisense IV infusion and Sorafenib
Type of treatment
Injection or infusion
How many people
75 participants
Where
3 sitesChina
Study dates
Mar 2009to May 2011
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

  • HCC diagnosed by:
  • Histology, or
  • AASLD Criteria in which the diagnosis is made clinically in a patient with a known hepatitis B or cirrhosis of other etiology has a liver mass of > 2cm with typical features of HCC (i.e., hypervascular with washout in the portal/venous phase) on a dynamic imaging study (contrast CT / USG / MRI) or alternatively if the AFP is >200 ng/ml.
  • The tumor is not suitable for curative treatment (resection / transplant / local ablative therapies) or the patient is medically inoperable or refuses such treatment.
  • At least one measurable lesion according to RECIST criteria.
  • Age > 18 years.
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  • Life expectancy of greater than 12 weeks.
  • ECOG performance status ≤ 2 (please refer to Appendix 1).
  • Child-Pugh score A or B (please refer to Appendix 2).
  • Adequate organ functions defined as:
  • ANC ≥ 1.5 x 109/L
  • Platelet count ≥ 75 x 109/L
  • Creatinine ≤ 1.5 x ULN
  • ALT or AST < 2.5 x ULN
  • Total bilirubin < 50 μmol/L
  • INR <1.7
  • No encephalopathy clinically
  • Normal ECG
  • For women of child-producing potential, the use of effective contraceptive methods during the study.
  • Prior local therapy to tumor (e.g. surgery, RFA, PEI, chemo-embolization, radiotherapy) is allowed provided that there is a target lesion not subjected to local therapy and/or disease progression has been documented in the target lesion subjected to local therapy. The treatment must be completed at least 4 weeks and patient has recovered from all the acute toxicities of that treatment.
  • For patients with hepatitis B, the patient must receive antiviral therapy prior to or with registration.

Who cannot join

  • Child-Pugh score C.
  • Patients who have had prior systemic chemotherapy.
  • Patients who have had any other cancer related therapy including radiotherapy within 4 weeks prior to entering the study.
  • Patients receiving any other investigational agents concurrently.
  • 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.
  • Patients who have peripheral neuropathy.
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  • Uncontrolled intercurrent disease such as, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known bleeding diathesis.
  • 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.
  • 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

3 sites in 1 country.

China3 sites

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Tuenmen, New Territories, Hong Kong

Other trials in China

About this study

Official title: A Phase 1-2, Open-Label Study of The X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

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. Advanced HCC is an attractive target for AEG35156 since XIAP is highly expressed in HCC and may prevent cancer cells from undergoing apoptosis. Second generation antisense molecules are known to accumulate in liver where AEG35156 may down regulate XIAP protein expression in HCC cells thus promoting their apoptotic death.

Being tested
AEG35156 antisense IV infusion, Sorafenib
Keywords
Advanced Hepatocellular carcinoma, liver, cancer, antisense, sorafenib
Medical subject headings
Neoplasms

What participants receive

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

  • AEG35156 antisense IV infusionDrug

    Dose escalation (100, 200 and 300 mg/day) over 2 hr infusion, once weekly over 21 days (Day 1, 8, 15)

  • SorafenibDrug

    Also called nexavar

    Sorafenib will be administered at 400 mg BID every day

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 in combination with sorafenib patients with advanced HCC

    13 patients were enrolled into the phase 1 dose escalation part of the study. The recommended dose was determined to be 300 mg.

    Measured: 12 months

  2. To evaluate the efficacy of AEG35156 in combination with sorafenib based on PFS(PII) using sorafenib alone for comparison

    Measured: 12 months

Secondary outcomes (2)

  1. To determine the safety profile of AEG35156 in combination with sorafenib in advanced HCC

    Measured: 12 months

  2. To determine the response rate of AEG35156 in combination with sorafenib in advanced HCC

    Measured: 12 months

Timeline

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

  1. First posted17 Apr 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2011
  4. Study completionMay 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00882869
Sponsor's protocol ID
AEG35156-205
Status last verified
Jul 2011
First submitted
16 Apr 2009
Last updated
13 Jul 2011
Results posted
No
Data monitoring committee
No

Publications

  • Lee FA, Zee BC, Cheung FY, Kwong P, Chiang CL, Leung KC, Siu SW, Lee C, Lai M, Kwok C, Chong M, Jolivet J, Tung S. Randomized Phase II Study of the X-linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC). Am J Clin Oncol. 2016 Dec;39(6):609-613. doi: 10.1097/COC.0000000000000099.

    PubMed 24977690

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AEG35156 antisense IV infusion and Sorafenib in people with Advanced Hepatocellular Carcinoma, run by Aegera Therapeutics at 3 sites in China.

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 14 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 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 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?

To determine the recommended dose of AEG35156 in combination with sorafenib patients with advanced HCC (time frame: 12 months). 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 NCT00882869, 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 13 Jul 2011.

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