Study of Axitinib and Temsirolimus in Solid Tumors

NCT ID: NCT01529138

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-03-31

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temsirolimus

An ester of the macrocyclic immunosuppressive agent sirolimus.

Group Type: EXPERIMENTAL

Temsirolimus

Intervention Type: DRUG

Combination treatment with temsirolimus and axitinib

Axitinib

An oral, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3.

Group Type: EXPERIMENTAL

Axitinib

Intervention Type: DRUG

Combination treatment with temsirolimus and axitinib

Interventions

Axitinib

Combination treatment with temsirolimus and axitinib

Intervention Type: DRUG

Temsirolimus

Combination treatment with temsirolimus and axitinib

Intervention Type: DRUG

Other Intervention Names

Inlyta; AG013736; Torisel; CCI-779

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Bradley Carthon MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bradley Carthon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

WCI1939-10

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00048705

Identifier Type: -

Identifier Source: org_study_id