OsteosarcomaPhase 1NCT03900793
Losartan + Sunitinib in Treatment of Osteosarcoma
A Phase 1 study testing Losartan and Sunitinib in people with Osteosarcoma, run by University of Colorado, Denver at 4 sites in United States.
Trial summary
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. Medication dosages will increase until a maximally tolerated dose is found. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Losartan and Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Aug 2019to 1 Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to 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 willingness to comply with all study procedures and be available for the duration of the study.
- 3. Male or female aged ≥ 10 years old. 4. Histologically confirmed osteosarcoma (at either original diagnosis or relapse) that has either recurred or progressed after at least one prior systemic therapy and for which no curative therapy exists.
- 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
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- 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:
- 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 required timeframe, the numerical eligibility criteria are met (e.g., blood count criteria) the patient is considered to have recovered adequately.
- 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.
- Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.
- Corticosteroids: ≥ 14 days must have elapsed since last dose of corticosteroid.
- Hematopoietic growth factors: ≥ 14 days after the last dose of a long- acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor.
- Interleukins, Interferons and Cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors).
- Stem cell Infusions: Autologous stem cell infusion, including boost infusion: ≥ 42 days.
- Cellular Therapy: ≥ 42 days after the completion of any type of cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.) vii. XRT/External Beam Irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial bone marrow radiation.
- NOTE: Patients with history of cardiac irradiation with mean cardiac dose > 15 Gy are not eligible (see exclusion criteria).
- 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 for patients with ≥ trace protein on urinalysis for consideration regarding Section 6.3.7 dose modification requirements.
- 12. Adequate cardiac function, defined as:
- 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 gastrostomy tube.
Who cannot join
- 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 anticoagulation course are eligible.
- 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.
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- 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 significant cardiac arrhythmias, stroke, or myocardial infarction are not eligible.
- 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 post-menarchal.
- 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 treatment period and through 3 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. Patients who themselves or their partners have undergone female or male sterilization do not require 2 methods of contraception. Highly effective methods are defined as those with <1% failure rate with perfect use and include: oral contraceptive pills (combined or progesterone only), intrauterine devices (IUD), hormonal implant or injection, contraceptive patch, and vaginal ring.
- 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 eligible. Patients who require treatment with enzyme inducing anticonvulsants are not eligible.
- Medications that prolong QTc: Patients who require treatment with medications known to prolong QTc are not eligible
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Children's Hospital of Atlanta
Atlanta, Georgia, 30322
Thomas Cash, MD, AflacDevTreferral@choa.org
Thomas Cash, MD
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Kelly Faulk, MD, kelly.faulk@childrenscolorado.org
Kelly Faulk, MD
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Kelly Faulk, MD, MSCS, 1-720-777-6503, kelly.faulk@childrenscolorado.org
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Fariba Navid, MD, 323-361-4624, fnavid@chla.usc.edu
About this study
Official title: A Phase I/Ib Study of Losartan in Combination With Sunitinib in the Treatment of Pediatric and Adult Patients With Relapsed or Refractory Osteosarcoma
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. Medication dosages will increase until a maximally tolerated dose is found. Patients will then be accrued to the Dose Expansion phase of the trial, where efficacy of pre-determined dose will be preliminarily assessed.
- Conditions
- Osteosarcoma
- Keywords
- Pediatrics, Adults, Phase 1, Losartan, Sunitinib, Maximum Tolerated Dose, Recommended Phase 2 Dose
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Losartan will be administered orally daily on days 1-42 (6 weeks) of each 42-day cycle according to assigned dose level. Dosing will be performed based on weight in kilograms and rounded to the nearest 12.5 mg (half of 25 mg tablet). Dose Levels 1 and 2 are closed to enrollment. Dose level 1 does not exceed 50mg daily. Dose level 2 does not exceed 100mg daily. Dose levels 3 and 4 do not exceed 150mg total daily. Doses should be taken at approximately the same time daily and patients should fast for at least 4 hours prior to and 1 hour after the morning dose. No fasting is required for evening dose.
SunitinibDrug
Also called Sunitinib Malate
Sunitinib will be administered orally daily on days 1-28 (4 weeks), followed by 14-day rest period (2 weeks). Dosing will be performed based on body surface area (BSA) in mg/m2. Sunitinib is given as capsules or liquid formulation. Doses should be taken at approximately the same time daily.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Participants receive losartan in combination with sunitinib in 42-day treatment cycles. During Part A, participants are enrolled using a standard 3+3 dose-escalation design across up to four dose levels. Dose Levels 1 and 2 utilized once-daily losartan dosing and are closed to enrollment. Active enrollment occurs at Dose Levels 3 and 4, where losartan is administered twice daily and sunitinib is administered daily for 4 weeks followed by a 2-week rest period. Following determination of the maximally tolerated dose (MTD), 12 additional participants are enrolled into an expansion cohort to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. Receives: Drug: Losartan; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination
Assessment of Dose-Limiting Toxicities (DLTs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 to assess the safety of the combination
Measured: Beginning of study to end of study, up to 4 years
Maximally Tolerated Dose of Losartan and Sunitinib
The MTD will be defined as the dose level below that at which 1/3 or 2/6 patients experience DLTs.
Measured: Beginning of study to end of study, up to 4 years
Recommended Phase 2 Dose of Losartan and Sunitinib
The dose than less that 33% of patients experience DLTs.
Measured: Beginning of study to end of study, up to 4 years
Secondary outcomes (9)
Pharmacokinetics of Losartan and Sunitinib in Pediatric and Adult Patients: Maximum Peak Concentration
Determined through blood samples
Measured: Days 1, 15, and 29 of Cycle 1 (Cycle length is 42 days)
Pharmacokinetics of Losartan and Sunitinib in Pediatric and Adult Patients: Time to Peak Concentration
Determined through blood samples
Measured: Days 1, 15, and 29 of Cycle 1 (Cycle length is 42 days)
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCL2-Mediated Chemotactic Index
Determined through a monocyte mitigation assay and reported as a change in chemotactic index from baseline
Measured: Beginning of study to end of treatment, up to 2 years (up to 17 cycles and cycle length is 42 days)
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: Plasma CCL2 Levels
Assessed by Enzyme Linked Immunosorbent Assay (ELISA).
Measured: Beginning of study to end of treatment, up to 2 years (up to 17 cycles and cycle length is 42 days)
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCR2+ Monocyte Population
Assessed by Flow Cytometry
Measured: Beginning of study to end of treatment, up to 2 years (up to 17 cycles and cycle length is 42 days)
Preliminary Antitumor Activity of Losartan and Sunitinib in Pediatric and Adult Patients: Disease Control Rate (DCR)
Stable disease determined according to RECIST 1.1 criteria
Measured: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Preliminary Antitumor Activity of Losartan and Sunitinib in Pediatric and Adult Patients: Disease Control Rate (DCR)
Partial response determined according to RECIST 1.1 criteria
Measured: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Preliminary Antitumor Activity of Losartan and Sunitinib in Pediatric and Adult Patients: Disease Control Rate (DCR)
Complete response determined according to RECIST 1.1 criteria
Measured: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Preliminary: Progression Free Survival (PFS)
Determined according to irRECIST criteria.
Measured: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start26 Aug 2019
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- During Part A, patients are enrolled using a standard 3+3 dose-escalation design across up to four dose levels. Losartan is initially escalated while sunitinib is administered at a fixed body-surface-area based dose. If tolerated, enrollment proceeds to a fourth dose level that includes escalation of sunitinib. Participants are monitored for dose-limiting toxicities during Cycle 1 to determine the maximally tolerated dose. Following determination of the MTD, Part B enrolls an expansion cohort of 12 additional participants treated at the MTD to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado, Colorado State University, Swim Across America
- Responsible party
- Sponsor
- Investigators
- Kelly Faulk, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900793
- Sponsor's protocol ID
- 18-2740.cc
- Other IDs
- NCI-2019-06119
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2019
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study of Losartan in Combination With Sunitinib in the Treatment of Pediatric and Adult Patients With Relapsed or Refractory Osteosarcoma
- ClinicalTrials.gov ID
- NCT03900793
- Acronym / sponsor ID
- 18-2740.cc
- Conditions
- Osteosarcoma
- Keywords
- Pediatrics, Adults, Phase 1, Losartan, Sunitinib, Maximum Tolerated Dose, Recommended Phase 2 Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cancer League of Colorado, Colorado State University, Swim Across America
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Medication dosages will increase until a maximally tolerated dose is found. Patients will then be accrued to the Dose Expansion phase of the trial, where efficacy of pre-determined dose will be preliminarily assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During Part A, patients are enrolled using a standard 3+3 dose-escalation design across up to four dose levels. Losartan is initially escalated while sunitinib is administered at a fixed body-surface-area based dose. If tolerated, enrollment proceeds to a fourth dose level that includes escalation of sunitinib. Participants are monitored for dose-limiting toxicities during Cycle 1 to determine the maximally tolerated dose. Following determination of the MTD, Part B enrolls an expansion cohort of 12 additional participants treated at the MTD to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: Losartan, Drug: SunitinibParticipants receive losartan in combination with sunitinib in 42-day treatment cycles. During Part A, participants are enrolled using a standard 3+3 dose-escalation design across up to four dose levels. Dose Levels 1 and 2 utilized once-daily losartan dosing and are closed to enrollment. Active enrollment occurs at Dose Levels 3 and 4, where losartan is administered twice daily and sunitinib is administered daily for 4 weeks followed by a 2-week rest period. Following determination of the maximally tolerated dose (MTD), 12 additional participants are enrolled into an expansion cohort to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (33 listed)
- 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 willingness to comply with all study procedures and be available for the duration of the study.
- 3. Male or female aged ≥ 10 years old. 4. Histologically confirmed osteosarcoma (at either original diagnosis or relapse) that has either recurred or progressed after at least one prior systemic therapy and for which no curative therapy exists.
- 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.
Key exclusion criteria (17 listed)
- 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 anticoagulation course are eligible.
- Patients with history of cardiac irradiation with mean cardiac dose > 15 Gy are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanLosartan will be administered orally daily on days 1-42 (6 weeks) of each 42-day cycle according to assigned dose level. Dosing will be performed based on weight in kilograms and rounded to the nearest 12.5 mg (half of 25 mg tablet). Dose Levels 1 and 2 are closed to enrollment. Dose level 1 does not exceed 50mg daily. Dose level 2 does not exceed 100mg daily. Dose levels 3 and 4 do not exceed 150mg total daily. Doses should be taken at approximately the same time daily and patients should fast for at least 4 hours prior to and 1 hour after the morning dose. No fasting is required for evening dose. | Drug | Dose Escalation and Expansion |
| SunitinibAlso: Sunitinib MalateSunitinib will be administered orally daily on days 1-28 (4 weeks), followed by 14-day rest period (2 weeks). Dosing will be performed based on body surface area (BSA) in mg/m2. Sunitinib is given as capsules or liquid formulation. Doses should be taken at approximately the same time daily. | Drug | Dose Escalation and Expansion |
Primary outcome
Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination
Time frame: Beginning of study to end of study, up to 4 years
Assessment of Dose-Limiting Toxicities (DLTs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 to assess the safety of the combination
Maximally Tolerated Dose of Losartan and Sunitinib
Time frame: Beginning of study to end of study, up to 4 years
The MTD will be defined as the dose level below that at which 1/3 or 2/6 patients experience DLTs.
Recommended Phase 2 Dose of Losartan and Sunitinib
Time frame: Beginning of study to end of study, up to 4 years
The dose than less that 33% of patients experience DLTs.
9 secondary outcomes
Pharmacokinetics of Losartan and Sunitinib in Pediatric and Adult Patients: Maximum Peak Concentration
Time frame: Days 1, 15, and 29 of Cycle 1 (Cycle length is 42 days)
Pharmacokinetics of Losartan and Sunitinib in Pediatric and Adult Patients: Time to Peak Concentration
Time frame: Days 1, 15, and 29 of Cycle 1 (Cycle length is 42 days)
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCL2-Mediated Chemotactic Index
Time frame: Beginning of study to end of treatment, up to 2 years (up to 17 cycles and cycle length is 42 days)
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: Plasma CCL2 Levels
Time frame: Beginning of study to end of treatment, up to 2 years (up to 17 cycles and cycle length is 42 days)
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCR2+ Monocyte Population
Time frame: Beginning of study to end of treatment, up to 2 years (up to 17 cycles and cycle length is 42 days)
Preliminary Antitumor Activity of Losartan and Sunitinib in Pediatric and Adult Patients: Disease Control Rate (DCR)
Time frame: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Preliminary Antitumor Activity of Losartan and Sunitinib in Pediatric and Adult Patients: Disease Control Rate (DCR)
Time frame: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Preliminary Antitumor Activity of Losartan and Sunitinib in Pediatric and Adult Patients: Disease Control Rate (DCR)
Time frame: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Preliminary: Progression Free Survival (PFS)
Time frame: Beginning of study, end of cycle 1 (each cycle is 6 weeks), and at the end of odd cycles (up to 17 cycles)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Faulk, MD principal investigator
Children's Hospital Colorado
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Losartan and Sunitinib in people with Osteosarcoma, run by University of Colorado, Denver at 4 sites in United States.
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 33 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Faulk, MD, MSCS (720-777-6503, kelly.faulk@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination (time frame: Beginning of study to end of study, up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.