Sunitinib in Refractory Adrenocortical Carcinoma

NCT00453895

Last updated date
Study Location
Charite Berlin
Berlin, , , Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adrenocortical Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed diagnosis of ACC

- Locally advanced or metastatic disease not amenable to radical surgery resection

- Radiologically monitorable disease

- Progressing disease after one to three cytotoxic chemotherapy regimes including a platin-based protocol

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Age ≥ 18 years

- Adequate bone marrow reserve (neutrophils ≥ 1500/mm³ and platelets ≥100.000/mm³) and haemoglobin ≥ 9 g/dl

- Negative pregnancy test and effective contraception in pre-menopausal female and male patients

- Patient´s written informed consent

- Ability to comply with the protocol procedures

- If patients have been participated in another clinical trial evaluating treatment options for ACC (e.g. FIRM-ACT), the patient can only be included in the SIRAC trial, if:

- the patient has discontinued study treatment of the previous trial according to the protocol

- or the study chair of the previous trial gives written approval for inclusion of this individual patient in the SIRAC trial.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ
cervical carcinoma, or other treated malignancies with no evidence of disease for at
least three years.


- Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / AST > 2.5
x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying
malignancy and/or total serum bilirubin > 2.0 x ULN) and/or serum albumin < 3g/dl


- Any of the following within the 8 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, pulmonary embolism, or other severe thromboembolic event.


- Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, acute atrial fibrillation of any
grade, or prolongation of the QTc interval to >470 msec for females


- Left ventricular ejection fraction (LVEF) <45% as measured by echocardiogram


- NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment


- Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal
medical therapy)


- Pregnancy or breast feeding


- Previous treatment with Sunitinib or any other VEGF- or PDGF-pathway directed agent.


- Current treatment with strong CYP3A4 inhibitors or -inducers


- Current treatment with another investigational drug


- Current treatment with another anti-cancer drug


- Patients with ileus within the last 28 days


- Major surgery, radiation therapy, or systemic therapy within 3 weeks of first study
treatment. At least 7 days should elapse from the time of minor surgical procedure
including placement of an access device or fine needle aspiration before start of
study treatment


- Serious wounds that have not completely healed, active ulcer(s), or significant bone
fracture(s).


- Prior radiation therapy to >25% of the bone marrow.


- Cachectic patients with a body mass index < 18 kg/m2


- Any other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into this
study.

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Adrenocortical CarcinomaSunitinib in Refractory Adrenocortical Carcinoma
NCT00453895
  1. Berlin,
  2. Wuerzburg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib in Refractory Adrenocortical Carcinoma
Official Title  ICMJE Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy
Brief Summary

Although a first randomized trial in patients with advanced ACC leading to the establishment of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating patients urgently need a new treatment option. However, up to date there is no evidence for a single regimen that might be promising in these treatment-refractory patients with ACC.

Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities, which is successfully tested in the treatment of patients with metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after failure of standard cytotoxic chemotherapy.

The primary objective of this trial is to estimate the response (defined as progression-free survival of ? 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC progressing after cytotoxic chemotherapy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adrenocortical Carcinoma
Intervention  ICMJE Drug: Sunitinib
50mg Sunitinib
Study Arms  ICMJE Experimental: Sunitinib

Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.

treatment will continue until progressive disease or unacceptable toxicity

Intervention: Drug: Sunitinib
Publications * Kroiss M, Quinkler M, Johanssen S, van Erp NP, Lankheet N, Pöllinger A, Laubner K, Strasburger CJ, Hahner S, Müller HH, Allolio B, Fassnacht M. Sunitinib in refractory adrenocortical carcinoma: a phase II, single-arm, open-label trial. J Clin Endocrinol Metab. 2012 Oct;97(10):3495-503. doi: 10.1210/jc.2012-1419. Epub 2012 Jul 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2018)
39
Original Enrollment  ICMJE
 (submitted: March 28, 2007)
36
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of ACC
  • Locally advanced or metastatic disease not amenable to radical surgery resection
  • Radiologically monitorable disease
  • Progressing disease after one to three cytotoxic chemotherapy regimes including a platin-based protocol
  • ECOG performance status 0-2
  • Life expectancy ? 3 months
  • Age ? 18 years
  • Adequate bone marrow reserve (neutrophils ? 1500/mm³ and platelets ?100.000/mm³) and haemoglobin ? 9 g/dl
  • Negative pregnancy test and effective contraception in pre-menopausal female and male patients
  • Patient´s written informed consent
  • Ability to comply with the protocol procedures
  • If patients have been participated in another clinical trial evaluating treatment options for ACC (e.g. FIRM-ACT), the patient can only be included in the SIRAC trial, if:

    • the patient has discontinued study treatment of the previous trial according to the protocol
    • or the study chair of the previous trial gives written approval for inclusion of this individual patient in the SIRAC trial.

Exclusion Criteria:

  • History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
  • Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.0 x ULN) and/or serum albumin < 3g/dl
  • Any of the following within the 8 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other severe thromboembolic event.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, acute atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec for females
  • Left ventricular ejection fraction (LVEF) <45% as measured by echocardiogram
  • NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
  • Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy)
  • Pregnancy or breast feeding
  • Previous treatment with Sunitinib or any other VEGF- or PDGF-pathway directed agent.
  • Current treatment with strong CYP3A4 inhibitors or -inducers
  • Current treatment with another investigational drug
  • Current treatment with another anti-cancer drug
  • Patients with ileus within the last 28 days
  • Major surgery, radiation therapy, or systemic therapy within 3 weeks of first study treatment. At least 7 days should elapse from the time of minor surgical procedure including placement of an access device or fine needle aspiration before start of study treatment
  • Serious wounds that have not completely healed, active ulcer(s), or significant bone fracture(s).
  • Prior radiation therapy to >25% of the bone marrow.
  • Cachectic patients with a body mass index < 18 kg/m2
  • Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00453895
Other Study ID Numbers  ICMJE SIRAC-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Fassnacht, University of Wuerzburg
Study Sponsor  ICMJE University of Wuerzburg
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Martin Fassnacht, MDUniversity of Wuerzburg
PRS Account University of Wuerzburg
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP