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New treatment option for Osteosarcoma
Official title Losartan + Sunitinib in Treatment of Osteosarcoma
ClinicalTrials.gov ID: NCT03900793
What this study is testing
What is Losartan?
Losartan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for osteosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a Phase 1/1b clinical trial that aims to determine the Maximally Tolerated Dose of Losartan and Sunitinib Combination Therapy. Patients will first be accrued to the Dose Escalation phase of the study, using a 3+3 design.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older
You may be able to join if
- 1\. Provision to sign and date the consent form (if individual is a minor, provision of a parent or legal guardian to sign and date the consent form...
- Patients with surface or periosteal osteosarcoma are not eligible.
- Patients with active CNS metastasis are not eligible. Previously treated CNS metastases which occurred 3 months or more prior, without evidence of...
- Dose Escalation (Part A): Patients must have measurable or evaluable disease.
- Cohort Expansion (Part B): Patients with measurable or evaluable disease and those with completely resected disease are eligible. 6\. Performance...
You likely can't join if
- ). 8\. Adequate bone marrow function, defined as:
- Peripheral absolute neutrophil count (ANC) ≥ 750/mm3
- Platelet count ≥ 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
- Hemoglobin ≥ 8 g/dL (with or without transfusion) 9. Adequate renal function, defined as:
- Creatinine clearance or radioisotope GFR \> 70 mL/min/1.73 m2 OR a serum creatinine based on age/gender. 10\. Adequate hepatic function, defined as:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
See the full eligibility criteria
Who can join
- 1\. Provision to sign and date the consent form (if individual is a minor, provision of a parent or legal guardian to sign and date the consent form and provision of individual to provide assent for study). 2\. Stated...
- Patients with surface or periosteal osteosarcoma are not eligible.
- Patients with active CNS metastasis are not eligible. Previously treated CNS metastases which occurred 3 months or more prior, without evidence of active recurrence, are acceptable. 5\. Disease status
- Dose Escalation (Part A): Patients must have measurable or evaluable disease.
- Cohort Expansion (Part B): Patients with measurable or evaluable disease and those with completely resected disease are eligible. 6\. Performance status:
- ECOG performance status (≥18 years old) ≤ 2 or Karnofsky performance score (\<18 years old)≥ 50. 7\. Prior Therapy:
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the...
- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).
- Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts): ≥ 7 days after the last dose of agent. i. Antibodies: ≥ 21 days must have elapsed from infusion of last...
- NOTE: Patients with history of cardiac irradiation with mean cardiac dose \> 15 Gy are not eligible (see
What rules you out
- ). 8\. Adequate bone marrow function, defined as:
- Peripheral absolute neutrophil count (ANC) ≥ 750/mm3
- Platelet count ≥ 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
- Hemoglobin ≥ 8 g/dL (with or without transfusion) 9. Adequate renal function, defined as:
- Creatinine clearance or radioisotope GFR \> 70 mL/min/1.73 m2 OR a serum creatinine based on age/gender. 10\. Adequate hepatic function, defined as:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
- SGPT (ALT) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
- Serum albumin ≥ 2.8 g/dL 11. Patients with ≥ trace protein on urinalysis at screening will be allowed to enroll in the study at investigator discretion. A baseline urine protein creatinine ratio (UPC) should be obtained...
- Current cardiac ejection fraction \> 50% by biplane Simpson method on echocardiogram
- QTc ≤ 480 ms 13. Patients with preexisting hyper- or hypothyroidism must be on a stable dose of medication. 14\. Ability to take and retain oral medications. NOTE: Medication can be administered via nasogastric or...
- Patients who underwent major surgery within 14 days prior to start of treatment are not eligible. NOTE: Core biopsy or central line placement are considered minor and are allowed within any time limitations.
- Patients with uncontrolled coagulopathy or bleeding disorder, or any active bleeding (i.e., gastrointestinal or pulmonary) deemed to be clinically significant by investigator are not eligible.
- Patients with history of pulmonary embolism or significant thromboembolic event with the preceding 28 days. Patients with thromboembolic events \> 28 days before enrollment who are stable on or completed an...
- Patients with history of cardiac irradiation with mean cardiac dose \> 15 Gy are not eligible.
- Patients with symptomatic cardiac disease (i.e. New York Heart Association or Modified Ross Heart Failure Classification for Children \> class 2) are not eligible.
- Patients with any history of cardiac dysfunction including prior abnormal echocardiogram (ejection fraction \< 50%), severe or unstable angina, peripheral vascular disease, congenital prolonged QTc syndrome, clinically...
- Pregnancy
- Pregnant or breast-feeding women will not be entered on this study because there is not yet available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in females who are...
- Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective (barrier) method of contraception at the same time during the entire study...
- Concomitant medications:
- Anti-hypertensives: Patients who cannot be controlled to goal blood pressure for gender/age are not eligible.
- Corticosteroids: Patients receiving systemic corticosteroids are not eligible. \> 14 days must have elapsed since last systemic corticosteroid. Note: patients using topical or inhaled corticosteroids are eligible.
- Investigational Drugs: Patients currently receiving another investigational drug are not eligible.
- Anti-cancer agents: Patients currently receiving other anti-cancer agents are not eligible.
- Drug interactions: Patients who require treatment with medications that are strong inhibitors or inducers of CYP3A4 or inhibitors of CYP2A9 or have received these medications in the 7 days prior to enrollment, are not...
- Medications that prolong QTc: Patients who require treatment with medications known to prolong QTc are not eligible
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.