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Resectable Soft Tissue SarcomaPhase 1NCT03217266

Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

A Phase 1 study testing Navtemadlin, Radiation Therapy and Surgical Procedure in people with Resectable Soft Tissue Sarcoma and Soft Tissue Sarcoma, run by National Cancer Institute (NCI) at 53 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase Ib trial studies the side effects of navtemadlin and radiation therapy in treating patients with soft tissue sarcoma. Navtemadlin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Navtemadlin, Radiation Therapy and Surgical Procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
53 sitesUnited States
Study dates
20 Jun 2018to 4 Sep 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PRIOR TO STEP 1 REGISTRATION INCLUSION CRITERIA
  • Patients with pathologically proven diagnosis of grade 2-3 (intermediate or high grade) soft tissue sarcoma with size >= 5 cm are eligible to enroll if the intention to treat is curative. They must have sufficient tissue to submit to central laboratory for review as well as for NGS sequencing (see submission requirement). Biopsy should be obtained within 180 days prior to registration. Availability of tumor tissue is mandatory for study eligibility. The patient must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue for future central pathology review, NGS sequencing and/or translational research
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 30 days prior to registration;
  • Imaging of the primary tumor by MRI and/or computed tomography (CT) with or without contrast and/or positron emission tomography (PET)/CT within 30 days prior to registration;
  • Staging workup evaluated by chest CT and/or PET/CT showing no distant metastasis within 30 days prior to registration
Show all 23Show fewer
  • There is a planned definitive surgical resection of the primary tumor
  • Eastern Cooperative Oncology Group (ECOG) or Zubrod performance status of 0-1 within 30 days prior to registration
  • Absolute neutrophil count >= 1500/uL (within 30 days prior to registration)
  • Platelet count >= 100,000/uL (within 30 days prior to registration)
  • Hemoglobin: >= 10 g/dL (transfuse as necessary to raise levels; no transfusions within 7 days of start) (within 30 days prior to registration)
  • Calculated creatinine clearance >= 60 ml/min (by Cockcroft-Gault formula) within 30 days prior to registration
  • The patient has an adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) or prothrombin time (PT) =< 1.5 x ULN, and partial thromboplastin time (PTT or aPTT) =< 1.5 x ULN (those receiving anticoagulation therapy except low molecular weight heparin are excluded) (within 30 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) appropriate for age (except for patients with Gilbert's syndrome, who must have a total bilirubin < 3 mg/dL) (within 30 days prior to registration)
  • Serum glutamic-oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT) alanine aminotransaminase (ALT) < 2.5 upper limit of normal (ULN) appropriate for age (within 30 days prior to registration)
  • Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to registration; exceptions: females not of child-bearing potential due to surgical sterilization (at least 6 weeks following tubal ligation, hysterectomy, or surgical bilateral oophorectomy with or without hysterectomy) confirmed by medical history; or female after menopause
  • A "postmenopausal woman" is a woman meeting either of the following criteria:
  • Spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example, oral contraceptives, hormones, gonadotropin releasing hormone, antiestrogens, selective estrogen receptor modulators [SERMs], or chemotherapy)
  • Spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level > 40 mIU/mL
  • Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 12 months following the last dose of study treatment; a highly effective method of birth control is defined as one that results in a low failure rate (that is, < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • PRIOR TO STEP 2 REGISTRATION INCLUSION CRITERIA
  • TP53 sequencing by NGS performed by central pathology lab

Who cannot join

  • PRIOR TO STEP 1 REGISTRATION EXCLUSION CRITERIA
  • Well-differentiated liposarcoma or other low grade STS; Kaposi sarcoma, bone sarcomas, cartilage sarcomas and gastrointestinal stromal tumor (GIST)
  • Definitive clinical or radiologic evidence of metastatic disease; indeterminant lung nodules less than 8 mm are acceptable
  • The patient has history of another primary malignancy, with the exception of
  • Curatively treated non-melanomatous skin cancer;
  • Curatively treated cervical carcinoma in situ;
Show all 27Show fewer
  • Non-metastatic prostate cancer
  • Other primary non-hematologic malignancies or solid tumor treated with curative intent, no known active disease, and no treatment administered during the last 3 years prior to registration
  • The patient has a serious cardiac condition, such as congestive heart failure; New York Heart Association class II/ III/IV heart disease; unstable angina pectoris, cardiac stenting within 6 months of enrollment; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment
  • Females who are pregnant or breastfeeding
  • Prior systemic chemotherapy for the study cancer (sarcoma); note that prior chemotherapy for a different cancer is allowable; however, unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (grade 2 or 3 toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 6 months], such as ifosfamide-related proteinuria, may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor)
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Clinically significant bleeding within 4 weeks of screening, current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors unless these medications can be safely discontinued 14 days prior to AMG-232 (KRT-232) administration; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AMG 232 (KRT-232)
  • All subjects must agree to stop the use of all herbal medicines (e.g., St. John's wort), and supplements, within the 10 days prior to receiving the first dose of AMG 232 (KRT-232), and during the protocol AMG 232 (KRT-232) treatment (weeks 1-5); subjects may renew the use of the above at week 6; standard adult multi-vitamin is allowed
  • All subjects must agree to stop the use of any known CYP3A4 substrates with narrow therapeutic window (such as alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, sirolimus, or terfenadine; within the 14 days prior to receiving the first dose of AMG 232 (KRT-232) and during protocol AMG 232 (KRT-232) treatment (weeks 1-5); other medications (such as fentanyl and oxycodone) may be allowed per investigator's assessment/evaluation
  • All subjects must agree to stop the use of any known CYP2C8 substrates with a narrow therapeutic window within the 14 days prior to receiving the first dose of AMG 232 (KRT-232) and during protocol AMG 232 (KRT-232) treatment (weeks 1-5)
  • All subjects are required to submit a list of medications consumed within 14 days prior to receiving the first dose of AMG232 (KRT-232) and during the protocol AMG232 (KRT-232) treatment (weeks 1-5)
  • Patients with gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis), therefore could affect the absorption of AMG 232 (KRT-232) at the discretion of treating physician
  • Patients with active infection requiring intravenous (IV) antibiotics within 2 weeks of registration
  • Patients with known positive hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B), positive hepatitis total core antibody with negative HBsAG (suggestive of occult hepatitis B), or detectable hepatitis C virus RNA by a polymerase-chain reaction (PCR) assay (indicative of active hepatitis C - screening is generally done by hepatitis C antibody (HepCAb), followed by hepatitis C virus RNA by PCR if HepCAb is positive)
  • Patients known to be positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:
  • A stable regimen of highly active anti-retroviral therapy (HAART)
  • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based test
  • HIV testing is not required
  • Treatment with medications known to cause corrected QT (QTc) interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • CTCA at Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Eastern Regional Medical Center

    Philadelphia, Pennsylvania, 19124

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

Other trials in United States

About this study

Official title: A Phase Ib Trial of Neoadjuvant AMG 232 (KRT-232) Concurrent With Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)

This phase Ib trial studies the side effects of navtemadlin and radiation therapy in treating patients with soft tissue sarcoma. Navtemadlin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving navtemadlin and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety and tolerability of navtemadlin (AMG-232 [KRT-232]) in combination with standard-dose radiotherapy in soft tissue sarcoma (STS) in two separate patient cohorts (A, extremity or body wall; B, abdomen/pelvis/retroperitoneum).

II. To determine the maximum tolerated dose/recommended phase II dose (maximum tolerated dose/recommended phase 2 dosage [MTD/RP2D]) of AMG 232 (KRT-232) in combination with radiotherapy.

SECONDARY OBJECTIVES:

  1. To observe and record anti-tumor activity. II. To determine percentage (%) necrosis and pathologic complete response (pCR) in final surgical resection specimen.

III. To determine % local failure (LF), disease free survival (DFS) and overall survival (OS) at 2 years.

IV. To determine pharmacodynamics (PD) effects of AMG 232 (KRT-232) when combined with radiotherapy by assessing serial serum macrophage inhibitory cytokine (MIC)-1 levels.

  1. To determine AMG 232 (KRT-232) exposure (pharmacokinetics)-response relationships (PD, toxicity, and efficacy).

EXPLORATORY OBJECTIVES:

  1. To determine tumor volume changes determined by magnetic resonance imaging (MRI) or computed tomography (CT) with and without contrast pre- and post-radiotherapy.

II. To characterize clinical outcomes in patients treated with AMG 232 (KRT-232) by genomic biomarkers.

III. To determine the correlation between mdm2/4 expression determined by next-generation sequencing (NGS) and the protein levels by immunohistochemistry (IHC).

IV. To explore the possibility of identifying tumor genetic mutations in (1) cell-free (cf) circulating tumor deoxyribonucleic acid (ctDNA), (2) deoxyribonucleic acid/ribonucleic acid (DNA/RNA) isolated from exosomes, and determine the concordance of these results and that from NGS.

OUTLINE: This is a dose-escalation study of navtemadlin.

STEP 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin orally (PO) on days 2-4, days 2-5, or days 1-5 of weeks 1 to 5 in the absence of disease progression or unacceptable toxicity.

STEP 2: Patients with a wild-type p53 gene status are assigned to Group I, while patients with deleted/mutant p53 gene status are assigned to Group II.

GROUP I: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy (RT) daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion.

GROUP II: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion.

After completion of study treatment, patients are followed up every 3 months for 2 years, and then at 2.5 years.

Being tested
Navtemadlin, Radiation Therapy, Surgical Procedure
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavtemadlinDrug

    Also called (3R,5R,6S)-5-(3-Chlorophenyl)-6-(4-chlorophenyl)-3-methyl-1-((1S)-2-methyl-1-(((1-methylethyl)sulfonyl)methyl)propyl)-2-oxo-3-piperidineacetic Acid, AMG 232, AMG-232, KRT 232

    Given PO

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo surgery

Study groups in NCT03217266
Study groupRoleWhat they receive
Step 1 (tumor tissue testing, navtemadlin)ExperimentalPatients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4, days 2-5, or days 1-5 of weeks 1 to 5 in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Navtemadlin; Radiation: Radiation Therapy
Step 2, Group I (navtemadlin, radiation therapy, surgery)ExperimentalStarting with week 2, patients receive navtemadlin as in Step 1 and undergo RT daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion.
Receives: Drug: Navtemadlin; Radiation: Radiation Therapy; Procedure: Surgical Procedure
Step 2, Group II (radiation therapy, surgery)ExperimentalStarting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion.
Receives: Radiation: Radiation Therapy; Procedure: Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dosage for Each Cohort

    Dose was determined separately for each cohort using the classic 3+3 design to determine the safety of each dose level from the number of participants with dose limiting toxicities (DLTs), starting with dose level 1. If dose level 1 were considered unsafe, a lower dose level of twice/week would be tested. The highest dose level deemed safe is considered the MTD. Five additional patients were accrued to the MTD to ensure safety.

    A DLT is defined as any grade 4-5 adverse event (AE) using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) that was definitely, probably, or possibly (DPP) related to navtemadlin or combined navtemadlin+RT ≤ 4 weeks after completing navtemadlin. Any grade 3 AE DPP related to navtemadlin/navtemadlin+RT was also considered a DLT if due to the grade 3 AE there was a delay of >2 weeks or if there were ≥ 2 dose reductions. CTCAE 5.0 Grade 3 is a severe AE, Grade 4 is a life-threatening or disabling AE, and Grade 5 results in death.

    Measured: Baseline to end of navtemadlin + 4 weeks (approximately 10 weeks total)

  2. Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)

    A DLT is defined as any grade 4-5 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) that was definitely, probably, or possibly related to navtemadlin or combined navtemadlin+RT up to 4 weeks after the completion of navtemadlin. Any grade 3 AE definitely, probably, or possibly related to navtemadlin or combined navtemadlin+RT was also considered DLT if any of the 2 following situations occurred: a delay of >2 weeks due to the grade 3 AE, or ≥ 2 dose reductions due to the grade 3 AE. CTCAE 5.0 Grade 3 is a severe AE, Grade 4 is a life-threatening or disabling AE, and Grade 5 results in death.

    Measured: Baseline to end of navtemadlin + 4 weeks (approximately 10 weeks total)

Secondary outcomes (7)

  1. Percent of Necrosis in Final Surgical Resection Specimen

    The evaluation for pathologic response will include a formal evaluation of percent necrosis according to the guidelines established for osteosarcoma and is determined by central pathological review.

    Measured: At time of surgery (approximately 11 to 14 weeks)

  2. Number of Participants With Pathologic Complete Response (PCR) in Final Surgical Resection Specimen

    Pathologic complete response is defined as 100% necrosis and is determined by central pathology review.

    Measured: At time of surgery (approximately 11 to 14 weeks)

  3. Number of Participants With Local Failure

    Local failure (LF) was defined as local recurrence or progression after surgery, or amputation for treatment complications or recurrence/progression. In addition, any patient that did not have surgery was considered to have local failure. Local progression was defined as at lease 20% increase in the maximal dimension of the primary tumor taking as reference the smallest maximal dimension recorded since treatment started.

    Measured: Baseline to the date of failure or last known follow-up, up to 2.5 years from end of RT (six weeks).

  4. Number of Participants With Disease or Death From Any Cause

    Disease is defined as any of the following:

    Local, regional, or distant disease.

    • Local disease: tumor recurrence or progression. Progression is defined as at 20% increase in the maximal dimension of the primary tumor taking as reference the smallest maximal dimension recorded since treatment started;
    • Regional disease: Any nodal metastasis adjacent to the primary soft tissue sarcoma;
    • Distant disease: Any tumor that develops distantly from the primary site of sarcoma;
    • Amputation for treatment complications or recurrence/progression.
    • Failure to continue to surgery.

    Measured: Baseline to the date of disease, death, or last known follow-up, up to 2.5 years from end of RT (six weeks).

  5. Number of Participants Who Died

    Death from any cause

    Measured: Baseline to the date of death or last known follow-up, up to 2.5 years from end of RT (six weeks).

  6. Serial Serum Macrophage Inhibitory Cytokine-1 Levels

    Will be tabulated and descriptive statistics and calculated for each dose level.

    Measured: Up to 2.5 years

  7. Navtemadlin Exposure-response Relationships

    Measured: Up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2017
  2. Study start20 Jun 2018
  3. Primary completion27 Aug 2023
  4. Study completion4 Sep 2025

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03217266
Sponsor's protocol ID
NCI-2017-01234
Other IDs
NCI-2017-01234, NRG-DT001, NRG-DT001, U10CA180868
Status last verified
Sep 2025
First submitted
13 Jul 2017
Last updated
23 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.

    PubMed 32827353

  • Elzanowska J, Semira C, Costa-Silva B. DNA in extracellular vesicles: biological and clinical aspects. Mol Oncol. 2021 Jun;15(6):1701-1714. doi: 10.1002/1878-0261.12777. Epub 2020 Aug 19.

    PubMed 32767659

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Navtemadlin, Radiation Therapy and Surgical Procedure in people with Resectable Soft Tissue Sarcoma and Soft Tissue Sarcoma, run by National Cancer Institute (NCI) at 53 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 23 inclusion and 27 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: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 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?

Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dosage for Each Cohort (time frame: Baseline to end of navtemadlin + 4 weeks (approximately 10 weeks total)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03217266, which also lists 2 linked publications.

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 23 Sep 2025.

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