Study of Axitinib and Temsirolimus in Solid Tumors

NCT01529138

Last updated date
Study Location
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer
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

/

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


- Patients must have histologically confirmed non-hematologic malignancy for which
standard curative or palliative measures do not exist or are no longer effective


- Patients with hepatocellular carcinoma do not need histologic confirmation of
malignancy if the following criteria were met at diagnosis:


- Liver lesions 1 - 2 cm with arterial enhancement and washout in venous phase of
CT/MRI


- Liver lesions ≥ 2 cm with arterial enhancement and washout in venous phase of
CT/MRI or serum alpha-feto protein ≥ 200 ng/mL


- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1


- Marrow and Organ function requirements:


- Absolute Neutrophil Count ≥ 1000/mm³


- Platelets ≥ 75,000/mm³


- Hemoglobin ≥ 9.0 g/dL


- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)


- Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present)


- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
(≤ 5 x ULN if liver metastasis present or patient has diagnosis of hepatocellular
carcinoma or cholangiocarcinoma)


- Creatinine ≤ 1.5 x ULN


- Urinalysis ≤ 1+ protein on dipstick or Urine creatinine:protein ratio < 1.0 If
urine protein >1 1+ or urine creatinine:protein ratio > 1, then 24 hour urine
protein should be obtained and the level should be < 1000 mg for patient
enrollment.


- Fasting serum cholesterol ≤ 350 mg/dL


- Triglycerides ≤1.5 x ULN


- Life expectancy ≥ 12 weeks


- At least 2 weeks since end of prior systemic treatment (4 weeks for bevacizumab
containing regimens), radiotherapy, or surgical procedure with resolution of all
treatment related toxicity


- No evidence of uncontrolled hypertension as evidenced by 2 readings of < 140/90
measured 1 hour apart. Preexisting hypertension controlled with medication is allowed


- No gastrointestinal disorders including active peptic ulcer disease (within 6 months);
active bleeding unrelated to malignancy; or melena, hematemesis, or hematochezia in
the past 3 months without endoscopically-proven resolution


- No cardiovascular history within 12 months including: myocardial infarction (MI),
uncontrolled angina, coronary artery bypass graft (CABG), or symptomatic congestive
heart failure (CHF)


- Women of child bearing potential must have negative pregnancy test


- Willingness and ability to comply with scheduled visits


- Able to ingest oral medications


- No concurrent use or anticipated need for potent cytochrome P450 3A4 (CYP3A4)
inhibitors or CYP3A4 or cytochrome P450 1A2 (CYP1A2) inducers

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Axitinib and Temsirolimus in Solid Tumors
Official Title  ICMJE Phase I Study of Axitinib and Temsirolimus in Solid Tumors
Brief Summary

This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment.

The combination of the drugs temsirolimus and axitinib has not been studied before so it is unknown whether this treatment will have any benefit in the patient's cancer.

Temsirolimus is commercially available and approved for treatment of some types of kidney cancer.

Axitinib has been tested in several diseases but it is not yet commercially available for the treatment of any cancer in the United States.

The combination of temsirolimus and axitinib is not approved for treatment of any cancer outside of a clinical trial.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: Axitinib
    Combination treatment with temsirolimus and axitinib
    Other Names:
    • Inlyta
    • AG013736
  • Drug: Temsirolimus
    Combination treatment with temsirolimus and axitinib
    Other Names:
    • Torisel
    • CCI-779
Study Arms  ICMJE
  • Experimental: Temsirolimus
    An ester of the macrocyclic immunosuppressive agent sirolimus.
    Intervention: Drug: Temsirolimus
  • Experimental: Axitinib
    An oral, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3.
    Intervention: Drug: Axitinib
Publications * Not Provided

*   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: September 8, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
50
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria/Exclusion Criteria:

  • Patients must have histologically confirmed non-hematologic malignancy for which standard curative or palliative measures do not exist or are no longer effective
  • Patients with hepatocellular carcinoma do not need histologic confirmation of malignancy if the following criteria were met at diagnosis:

    • Liver lesions 1 - 2 cm with arterial enhancement and washout in venous phase of CT/MRI
    • Liver lesions ? 2 cm with arterial enhancement and washout in venous phase of CT/MRI or serum alpha-feto protein ? 200 ng/mL
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Marrow and Organ function requirements:

    • Absolute Neutrophil Count ? 1000/mm³
    • Platelets ? 75,000/mm³
    • Hemoglobin ? 9.0 g/dL
    • Total bilirubin ? 1.5 x upper limit of normal (ULN)
    • Alkaline phosphatase ? 2.5 x ULN (? 5 x ULN if liver metastasis present)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN (? 5 x ULN if liver metastasis present or patient has diagnosis of hepatocellular carcinoma or cholangiocarcinoma)
    • Creatinine ? 1.5 x ULN
    • Urinalysis ? 1+ protein on dipstick or Urine creatinine:protein ratio < 1.0 If urine protein >1 1+ or urine creatinine:protein ratio > 1, then 24 hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment.
    • Fasting serum cholesterol ? 350 mg/dL
    • Triglycerides ?1.5 x ULN
  • Life expectancy ? 12 weeks
  • At least 2 weeks since end of prior systemic treatment (4 weeks for bevacizumab containing regimens), radiotherapy, or surgical procedure with resolution of all treatment related toxicity
  • No evidence of uncontrolled hypertension as evidenced by 2 readings of < 140/90 measured 1 hour apart. Preexisting hypertension controlled with medication is allowed
  • No gastrointestinal disorders including active peptic ulcer disease (within 6 months); active bleeding unrelated to malignancy; or melena, hematemesis, or hematochezia in the past 3 months without endoscopically-proven resolution
  • No cardiovascular history within 12 months including: myocardial infarction (MI), uncontrolled angina, coronary artery bypass graft (CABG), or symptomatic congestive heart failure (CHF)
  • Women of child bearing potential must have negative pregnancy test
  • Willingness and ability to comply with scheduled visits
  • Able to ingest oral medications
  • No concurrent use or anticipated need for potent cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 or cytochrome P450 1A2 (CYP1A2) inducers
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529138
Other Study ID Numbers  ICMJE IRB00048705
WCI1939-10 ( Other Identifier: Other )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bradley Carthon MD, PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Bradley Carthon, MD, PhDEmory University Winship Cancer Institute
PRS Account Emory University
Verification Date April 2015

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