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Hepatocellular CarcinomaPhase 1/2NCT01335074

Temsirolimus + Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

A Phase 1/2 study testing Temsirolimus + Sorafenib in people with Hepatocellular Carcinoma, run by Philipps University Marburg at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Sorafenib is the standard therapy for advanced liver cancer but often shows dose-limiting toxicities with the need to reduce the applied dose of the compound. As this limits the overall response rate of the therapy, a combination with temsirolimus, an inhibitor of mTOR signaling, will be investigated regarding safety… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Temsirolimus + Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteGermany
Study dates
Apr 2011to Dec 2013
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

  • Male or female patients ≥ 18 years of age
  • Patients who have a live expectancy of at least 12 weeks
  • Patients with histologically or radiologically and serologically confirmed advanced HCC; documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable
  • At least one tumor lesion that can be accurately measured in at least one dimension according to RECIST and which has not been treated with local therapy (TACE, PEI, radiofrequency ablation); CT or MRI scans should be not more than 2 weeks old to be used as baseline scan
  • Patients who received sorafenib at 400 mg bid with consecutive dose reduction to 200 mg bid due to intolerance, toxicity or adverse events or patients who are not eligible for full-dose first-line therapy with sorafenib, e.g. due to myocardial ischemia.
  • At least a period of 4 weeks prior to baseline scan after completion of a local therapy such as surgery, radiation therapy, hepatic arterial embolization, TACE, PEI, radiofrequency ablation, cryoablation or others
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  • Patients who have an ECOG PS of 0, 1 or 2 or a Karnofsky Performance Status > 70 %
  • Cirrhotic status of Child-Pugh class A or B; Child-Pugh status should be calculated based on clinical findings and laboratory results during the sorafenib pretreatment period
  • No signs of decompensated liver cirrhosis
  • White blood cells ≥ 3,000/mm³
  • Neutrophils ≥ 1,500/mm³
  • Platelets ≥ 100,000/mm³
  • Bilirubin ≤ 3x ULN
  • AST and ALT ≤ 3x ULN
  • Creatinine normal
  • PTT ≤ 1.5 ULN
  • INT 2.0 to 3.0
  • Fasting serum cholesterol ≤ 350 mg/dL
  • Triglycerides ≤ 300 mg/dL
  • Proteinuria ≤ 1 g in 24 h
  • No history of allergic reactions to compounds similar to temsirolimus or sorafenib
  • No prior thromboembolic disease
  • No history of hematemesis or hemoptysis
  • No other uncontrolled illness
  • Women of childbearing potential must have had a negative serum or urine pregnancy test 48 h prior to the administration of the first study treatment
  • Patients who give a written informed consent obtained according to local guidelines
  • No other concurrent investigational drugs or anticancer agents
  • No concurrent traditional Chinese or herbal medicine (e.g. sho-saiko-to, silymarine)

Who cannot join

  • Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these with 4 weeks of study entry except for standard sorafenib therapy
  • Prior use of systemic investigational agents for HCC
  • Previous concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors and any cancer curatively treated > 3 years prior to entry is permitted
  • Chronic treatment with steroids or another immunosuppressive agents
  • A known history of HIV seropositivity
  • Renal failure requiring hemo- or peritoneal dialysis
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  • History of cardiac disease: congestive heart failure (NYHA > 2), active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than b-blockers or digoxin, uncontrolled hypertension; myocardial infarction more than 6 months prior to study entry is permitted
  • Comedication with known strong Cyp3A4 inhibitors or Cyp3A4/5 inducers
  • Active clinically serious infections (> grade 2 CTCAE v.3.0)
  • Known carcinomatous meningitis or uncontrolled brain disease
  • Patients with clinically significant gastrointestinal bleeding with 30 days prior to study entry or on oral anti-vitamin K medication (except low dose coumarin, i.e. INR outside the therapeutic range of 2.0 to 3.0)
  • History of organ allograft
  • Uncontrolled diabetes
  • Impairment of gastrointestinal function of gastrointestinal disease that may significantly alter the absorption of sorafenib (e.g. ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
  • Patients who have not recovered from surgery
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes
  • Patients who are using other investigational agents or who had received investigational drugs < 4 weeks prior to study entry
  • Patients with contraindications to sorafenib or temsirolimus treatment.
  • History of noncompliance to medical regimens
  • Patients unwilling or unable to comply with the protocol
  • Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Giessen and Marburg

    Marburg, 35043

Other trials in Germany

About this study

Official title: Temsirolimus for the Treatment of Advanced Hepatocellular Carcinoma in Patients With Intolerance to Sorafenib

Sorafenib is the standard therapy for advanced liver cancer but often shows dose-limiting toxicities with the need to reduce the applied dose of the compound. As this limits the overall response rate of the therapy, a combination with temsirolimus, an inhibitor of mTOR signaling, will be investigated regarding safety and tolerability in patients with advanced liver cancer under a reduced dose of sorafenib.

Read the detailed description

Inhibitors of the PI3K/Akt and mTOR signaling pathway have recently been established as novel potent anti-cancer agents for solid and hematologic malignancies. Several pre-clinical reports have shown a good anti-tumor activity in different HCC models and first reports from clinical trials in HCC promise a good efficacy in inhibiting angiogenesis and tumor cell growth. mTOR inhibition has also been shown to enhance the activity of other cytotoxic agents.

Sorafenib also interferes with tumor cell survival, proliferation and angiogenesis by inhibiting molecular pathways independent of the PI3K/Akt/mTOR signaling. We therefore expect an at least additive effect by inhibiting two parallel but independent intracellular pathways in HCC tumor cells that will prolong overall survival and time to progression.

Being tested
Temsirolimus + Sorafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Temsirolimus + SorafenibDrug

    200mg bid Sorafenib + 15, 20 or 25 mg Temsirolimus

Study groups in NCT01335074
Study groupRoleWhat they receive
Temsirolimus + SorafenibExperimentalNot described
Receives: Drug: Temsirolimus + Sorafenib

What is being measured

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

  1. Maximum Tolerated Dose

    Measured: 12 weeks

Secondary outcomes (1)

  1. Overall response rate

    Measured: 12 weeks

Timeline

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

  1. First posted13 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2013 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01335074
Sponsor's protocol ID
MRHCCTS2010
Status last verified
Apr 2011
First submitted
12 Apr 2011
Last updated
15 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Temsirolimus + Sorafenib in people with Hepatocellular Carcinoma, run by Philipps University Marburg at 1 site in Germany.

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 28 inclusion and 21 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: withdrawn, as of the sponsor's last update on 15 Nov 2016. 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 Germany. 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 withdrawn before enrolling participants, so there are no results.

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?

Maximum Tolerated Dose (time frame: 12 weeks). 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 NCT01335074.

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 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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