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Clinical Stage IV Gastric Cancer AJCC v8Phase 1NCT04329494

PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

A Phase 1 study testing Biopsy, Cisplatin and Doxorubicin in people with Clinical Stage IV Gastric Cancer AJCC v8 and Clinical Stage IVA Gastric Cancer AJCC v8, run by City of Hope Medical Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy, Cisplatin and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
3 sitesUnited States
Study dates
21 Aug 2020to 5 Jan 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative
  • Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC
  • Prior IP chemotherapy is permitted
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelets >= 100,000/mm^3
Show all 26Show fewer
  • Hemoglobin >= 9 g/dl
  • Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to have chronic liver disease (hepatitis) in which case AST and ALT must be =< 5 x ULN
  • Alkaline phosphatase =< 2 x ULN
  • Serum creatinine (sCr) =< 1.5 x ULN, or creatinine clearance (Ccr) >= 40 ml/min as calculated by the Cockcroft-Gault formula
  • No contraindications for a laparoscopy
  • The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy
  • Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy
  • For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is define as:
  • Amenorrhea >= 12 consecutive months without another cause or
  • For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
  • Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
  • INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:
  • PIPAC access is feasible
  • There is room for aerosol therapy
  • There is no evidence of impending bowel obstruction
  • =< 5 L of ascites
  • Not a candidate for cytoreduction and HIPEC

Who cannot join

  • Gastric and colorectal/appendiceal:
  • Extra-peritoneal metastatic disease
  • Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
  • Arm 2 (colorectal/appendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency
  • Arm 2 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
  • Arm 2 (colorectal/appendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds
Show all 43Show fewer
  • Arm 2 (colorectal/appendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted
  • Arm 2 (colorectal/appendiceal): Life expectancy of less than 6 months
  • Arm 2 (colorectal/appendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents
  • Arm 2 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used
  • Arm 2 (colorectal/appendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents
  • Arm 2 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis
  • Arm 2 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection
  • Arm 2 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment
  • Arm 2 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
  • Arm 2 (colorectal/appendiceal): Involvement in the planning and conduct of the study
  • Arm 2 (colorectal/appendiceal): Pregnancy
  • Arm 2 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Arm 2 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months
  • Arm 2 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
  • Arm 2 (colorectal/appendiceal): Exclusive total parenteral nutrition
  • Arm 2 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
  • Arm 3 (colorectal/appendiceal): Progression on first- AND second-line systemic therapy
  • Arm 3 (colorectal/appendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy
  • Arm 3 (colorectal/appendiceal): Intolerance to prior 5-FU at 2400mg/m^2 IV every 2 weeks or to irinotecan at 180mg/m^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of > 1 week due to toxicity
  • Arm 3 (colorectal/appendiceal): Known DPD deficiency
  • Arm 3 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
  • Arm 3 (colorectal/appendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted
  • Arm 3 (colorectal/appendiceal): Life expectancy of less than 6 months
  • Arm 3 (colorectal/appendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents
  • Arm 3 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used
  • Arm 3 (colorectal/appendiceal): Patients may not be receiving any other investigational anti-cancer agents
  • Arm 3 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis
  • Arm 3 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection
  • Arm 3 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment
  • Arm 3 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
  • Arm 3 (colorectal/appendiceal): Involvement in the planning and conduct of the study
  • Arm 3 (colorectal/appendiceal): Pregnancy
  • Arm 3 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Arm 3 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months
  • Arm 3 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
  • Arm 3 (colorectal/appendiceal): Exclusive total parenteral nutrition
  • Arm 3 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites, 2 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Thanh H. Dellinger, 626-218-1379, tdellinger@coh.org

    Thanh H. Dellinger

    Recruiting

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Richard L. Whelan, 212-434-4860, rwhelan1@northwell.edu

    Richard L. Whelan

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Active, not recruiting

Other trials in United States

About this study

Official title: Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)

This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 3 groups of patients: peritoneal carcinomatosis (PC) due to primary ovarian, uterine, or gastric carcinoma (Arm 1); PC due to primary colorectal or appendiceal carcinoma (Arm 2).

II. To evaluate safety of PIPAC and identify the maximum tolerated dose (MTD) of PIPAC with MMC in patients with PC due to colorectal or appendiceal carcinoma (Arm 3).

SECONDARY OBJECTIVES:

  1. Ability to proceed to cytoreduction with/without hyperthermic intraperitoneal chemotherapy (HIPEC) (Arm 3 patients).

II. Efficacy will be assessed by:

Ia. Response Evaluation Criteria in Solid Tumors (RECIST), if available, version 1.1 via computed tomography (CT) scan at baseline (week 10, and 6 weeks after completing treatment; and at 18 weeks).

Ib. Peritoneal regression grading score (PRGS) via biopsy at each cycle (both pre-PIPAC and post-PIPAC peritoneal samples will be obtained).

Ic. Peritoneal carcinomatosis index (PCI) at the time of laparoscopy. II. Post-operative surgical complications by Claven-Dindo classification evaluated at 4, 10, and 16 weeks (4 weeks after each PIPAC).

III. Progression-free survival. IV. PIPAC technical failure rate. V. Patient-reported health state/quality of life and symptoms before treatment and at 6, 12, and 18 weeks as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) and MD Anderson Symptom Inventory (MDASI).

VI. Functional status, as measured by the number of daily steps before and after treatments (Vivofit 4 wristband pedometer - Garmin Company).

EXPLORATORY OBJECTIVE:

  1. Correlative/translational studies to characterize the tumor microenvironment, subclonal evolution, genomics, and pharmacokinetics of peritoneal tumors.

OUTLINE: Patients are assigned to 1 of 3 arms.

ARM I: Patients with ovarian, uterine, or gastric cancer, undergo PIPAC with doxorubicin intraperitoneally (IP), followed by cisplatin IP. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients with colorectal or appendiceal cancer undergo PIPAC with oxaliplatin IP. For cycles 2 and 3, patients receive leucovorin intravenously (IV) over 10 minutes and fluorouracil IV over 15 minutes 1-24 hours before undergoing PIPAC. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

ARM III: Patients with colorectal or appendiceal cancer who have undergo at least 4 months (or 8 cycles) of first-line standard of care chemotherapy but have not progressed on second line chemotherapy undergo PIPAC with mitomycin IP. Patients also receive standard of care irinotecan IV over 90 on day 1, leucovorin IV over 30 minutes on day 1, and fluorouracil IV on days 1-2 during weeks 2, 4, 8, 10, 14 and 16. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks for up to 3 years.

Being tested
Biopsy, Cisplatin, Doxorubicin, Fluorouracil, Intraperitoneal Chemotherapy
Medical subject headings
Uterine Neoplasms, Appendiceal Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Peritoneal Neoplasms

What participants receive

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

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given via PIPAC

  • DoxorubicinDrug

    Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

    Given via PIPAC

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given IV

  • Intraperitoneal ChemotherapyDevice

    Also called Intraperitoneal Therapy

    Undergo PIPAC

  • IrinotecanDrug

    Given IV

  • LeucovorinDrug

    Also called Folinic acid

    Given IV

  • MitomycinDrug

    Also called Ametycine, Jelmyto, MITO, Mito-C

    Given via PIPAC

  • OxaliplatinDrug

    Also called 1-OHP, Ai Heng, Aiheng, Dacotin

    Given via PIPAC

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04329494
Study groupRoleWhat they receive
Arm I (PIPAC, doxorubicin, cisplatin) - Not recruitingExperimentalPatients with ovarian, uterine, or gastric cancer, undergo PIPAC with doxorubicin IP, followed by cisplatin IP. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Procedure: Biopsy; Drug: Cisplatin; Drug: Doxorubicin; Device: Intraperitoneal Chemotherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (PIPAC, oxaliplatin, leucovorin, fluorouracil) - Not recruitingExperimentalPatients with colorectal or appendiceal cancer undergo PIPAC with oxaliplatin IP. For cycles 2 and 3, patients receive leucovorin IV over 10 minutes and fluorouracil IV over 15 minutes 1-24 hours before undergoing PIPAC. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Procedure: Biopsy; Drug: Fluorouracil; Device: Intraperitoneal Chemotherapy; Drug: Leucovorin; Drug: Oxaliplatin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm III (PIPAC, mitomycin, FOLFIRI) - Not recruitingExperimentalPatients with colorectal or appendiceal cancer who have undergo at least 4 months (or 8 cycles) of first-line standard of care chemotherapy but have not progressed on second line chemotherapy undergo PIPAC with mitomycin IP. Patients also receive standard of care irinotecan IV over 90 on day 1, leucovorin IV over 30 minutes on day 1, and fluorouracil IV on days 1-2 during weeks 2, 4, 8, 10, 14 and 16. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Procedure: Biopsy; Drug: Fluorouracil; Device: Intraperitoneal Chemotherapy; Drug: Irinotecan; Drug: Leucovorin; Drug: Mitomycin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm IV (PIPAC, Cisplatin and nab-paclitaxel) - only ovarian cancer patients are eligibleExperimentalPatients with recurrent ovarian cancer ( platinum-resistent or platinum metastases) patients with unresectable peritoneal metastases who are not candidates for cytoreductive surgery, at least 6 months after completion of first-line standard of care chemotherapy, and no bowel obstruction. Treatment for each 28-day cycle will consist of PIPAC with cisplatin (15 mg/m2) and nab-paclitaxel (90 mg/m2) on D1 every 28 days. A dose de-escalation plan is provided if the starting dose is not well-tolerated.

What is being measured

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

  1. Dose limiting toxicities

    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome.

    Measured: Up to 18 weeks

  2. Incidence of adverse events

    Assessed using CTCAE v.5.0. Summarized by grade and attribution. Post-surgical complications will be assessed by Clavien-Dindo classification.

    Measured: From day 1 of protocol therapy until week 18

Secondary outcomes (8)

  1. Percentage of evaluable patients who have achieved complete response (CR), partial response (PR), or stable disease (SD)

    Assessed by Response Evaluation Criteria in Solid Tumors criteria version 1.1 via computed tomography (CT) scan. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach by Clopper and Pearson.

    Measured: At baseline, following the second cycle (week 10), and 6 weeks after completing treatment (at 18 weeks/off-study)

  2. Percentage of evaluable patients who have achieved CR, PR, or SD

    Assessed by Peritoneal Carcinomatosis Index. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach by Clopper and Pearson.

    Measured: At the time of laparoscopy (or CT imaging if laparoscopy is not planned during surgery)

  3. Percentage of evaluable patients who have achieved a decrease in Peritoneal Regression Grading Score over successive biopsies

    The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach by Clopper and Pearson.

    Measured: Up to 18 weeks

  4. Progression-free survival

    Described using the Kaplan-Meier method.

    Measured: Time from first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) procedure, assessed up to 1 year

  5. Post-surgical complications

    Assessed by Clavien-Dindo classification. Results will be strictly descriptive in nature.

    Measured: At 4 weeks after each PIPAC

  6. PIPAC technical failure rate

    Measured: Up to 3 years

  7. Functional status

    Measured by the number of daily steps before and after treatments (Vivofit 4 wristband pedometer - Garmin Company).

    Measured: Up to 18 weeks

  8. Cytoreductive surgery rate (Arm 3)

    Measured: Up to 18 weeks

Timeline

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

  1. First posted1 Apr 2020
  2. Study start21 Aug 2020
  3. Primary completion5 Jan 2028 (estimated)
  4. Study completion5 Jan 2028 (estimated)

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
Parallel groups
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04329494
Sponsor's protocol ID
19184
Other IDs
NCI-2020-01254, 19184, P30CA033572
Status last verified
Aug 2026
First submitted
13 Mar 2020
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biopsy, Cisplatin and Doxorubicin in people with Clinical Stage IV Gastric Cancer AJCC v8 and Clinical Stage IVA Gastric Cancer AJCC v8, run by City of Hope Medical Center at 3 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 26 inclusion and 43 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (time frame: Up to 18 weeks). 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 NCT04329494.

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 26 Aug 2026.

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