ClinicalTrials.gg
Not yet recruitingNCT07935928Updated Nov 13, 2026

A Multicenter Study Evaluating the Efficacy and Safety of Nivolumab and Ipilimumab in Combination With NP-101 Versus Placebo in Refractory Advanced and Metastatic Gastroenteropancreatic Neuroendocrine Carcinomas (GEP-NECs)

A Phase 2/3 interventional study of NP-101 and Placebo in Gastroenteropancreatic Neuroendocrine Tumors, sponsored by Novatek Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Novatek Pharmaceuticals · Phase 2/3, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 2/3
Study type
Interventional
Enrollment
381
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This clinical trial uses a study drug (NP-101) alone in some parts of the study or with a recommended treatment for GEP-NEC called Nivo/Ipi (a combination of Nivolumab and Ipilimumab) in other parts of the study and tests it against Placebo (look alike capsules with no active drug) with Nivo/Ipi. The study is divided into three parts. Participants will participate in only one of 3 study parts: Part 1- Dose escalation or Part 2 - Dose selection or Part 3 - Selected dose continuation.

The goal of this clinical trial is to learn if NP-101 (the study drug) can help people with poorly differentiated GEP-NEC live longer; the study includes males and females, age 18 and older who agree to join the study and who qualify.

The main questions the study seeks to answer:

  1. Is the study drug in combination with Nivo/Ipi safe?
  2. How does the body process the study drug alone and in combination with Nivo/Ipi?
  3. How does the body process the study drug with and without food?
  4. Can the study drug plus Nivo/Ipi (the recommended treatment) help people with GEP-NEC live longer than people who do not take the study drug, but who do receive recommended treatment?

Participants will be asked to report how they are feeling, allow for blood draws, body scans, visit the clinic for testing, allow for removal of tumor tissue, take study drug or capsules without medication (along with the recommended treatment) and other procedures which will be explained, along with the study visit schedule, in detail by the study staff before agreeing to participate.

02

Conditions studied

  • Gastroenteropancreatic Neuroendocrine Tumors

Keywords

  • GEP-NEC
  • Gastroenteropancreatic Neuroendocrine Carcinoma
  • Refractory GEP-NEC
  • Metastatic GEP-NEC
  • Poorly Differentiated GEP NEC
03

In context

Gastro-enteropancreatic neuroendocrine tumor

73 studies on the registry are indexed under Gastro-enteropancreatic neuroendocrine tumor; 25 are open to participants now.

This study's planned enrollment of 381 is above the median of 53 across 49 interventional studies indexed under Gastro-enteropancreatic neuroendocrine tumor.

Browse Gastro-enteropancreatic neuroendocrine tumor studies →

Lead sponsor

Novatek Pharmaceuticals is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >18 years.
  • Participants must have or cytologically confirmed unresectable advanced and/or high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP-NECs) and have failed at least one .
  • Participants must have received at least one prior therapy for this disease, including platinum therapy. Participants must have recovered from acute toxicities of prior chemotherapy. Any prior non-hematologic vital organ toxicity (cardiac, pulmonary, hepatic, and renal) of previous therapy must have resolved to grade 1 or less. Neurological toxicities must have resolved to grade 2 or less.
  • Participants must have radiologic disease measurable by v1.1 criteria.
  • All previous chemotherapy, drugs, or radiation must be completed at least three weeks prior to starting study treatment.
  • Performance status Performance status ≤ 2
  • Participants must have adequate organ and marrow function as defined by all the below parameters:

    • ≥8.0g/dl
    • ≥1,000/µcL
    • count ≥70,000/µcL
    • Total \< 1.5 X institutional (IULN).
    • (SGOT) ≤ 3 X IULN.
    • ALT (SGPT) ≤ 3 X IULN.
    • AST or ALT ≤ 5 × ULN for participants with liver metastases.
    • Calculated ≥ 45 mL/min.
    • Serum albumin ≥ 25 g/L (2.5 g/dL)
  • Participants must have the ability to understand and the willingness to sign a written document.
  • Female participants of and male participants with a partner of childbearing potential must agree to practice reliable or to practice abstinence for at least 28 days before starting treatment and for at least 60 days after the last dose of NP-101, and for at least 5 months after last dose of nivolumab and for at least 3 months after the last dose of ipilimumab, whichever is later. Reliable contraception is defined as:

One highly effective method and one additional effective (barrier) method:

Examples of highly effective methods:

  • Intrauterine device (IUD)
  • Hormonal (injections, implants, levonorgestrel releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g., desogestrel])
  • Tubal ligation
  • Partner's vasectomy

Examples of additional effective methods:

  • Male condom
  • Diaphragm
  • Cervical Cap
  • Participants must agree to not donate eggs or sperm starting at screening and throughout the study period, and for at least 60 days after the last dose of NP-101, and for at least 5 months after the last dose of nivolumab and for at least 3 months after the last dose of ipilimumab, whichever is later The presence of any of the following will exclude a participant from study enrollment.

    • Pulmonary neuroendocrine carcinoma (Small cell or non-small cell) are excluded from this trial.
    • Well differentiated GEP-NETs are excluded from this trial.
    • Prior treatment toxicities that have not resolved to ≤ Grade 2 according to Version 5.0 (list exceptions, e.g. alopecia, neuropathy, etc.).
    • Participants received prior nivolumab or ipilimumab.
    • Participants with untreated /CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with treated CNS metastases will be considered for the study.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to NP-101 or immunotherapy (nivolumab or ipilimumab) used in this study.
    • Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • on an (ECG) corrected for heart rate using Fridericia's formula (QTcF) > 470 ms (males) or > 480 ms (females) at screening (any 2 of 3 triplicate ECGs)
    • Solid organ or hematopoietic stem cell transplant recipients.
    • Participants with significant disease requiring treatment, and participants with active interstitial lung disease or pneumonitis.
    • Participants who have a diagnosis of immunodeficiency or are receiving systemic therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiological doses of corticosteroids may be approved after consultation with the Sponsor. Examples of physiological doses of steroids include: Hydrocortisone: 10-25 mg total daily dose, Prednisone or Prednisolone: 4-10 mg daily, and Methylprednisolone: 3-5 mg daily.
    • Pregnant or breastfeeding women are excluded from this study.
    • Known chronic active untreated or C infection.
    • -positive participants on combination antiretroviral therapy.
    • Participants with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of NP-101 capsules
    • Current use, or use within 14 days prior to first dose (or [5 half-lives / documented induction offset period], whichever is longer), of any strong or moderate inducer of , CYP1A2, CYP2C9, or CYP2D6, including but not limited to those listed in Table 7
    • Current use of any medication that is a sensitive substrate of CYP2C9, CYP3A4, CYP1A2, or CYP2D6 with a narrow therapeutic index (including but not limited to warfarin, phenytoin, and other agents listed in Table 8), unless an alternative non-interacting agent is available, or unless the Investigator/Medical Monitor determines the patient can be safely managed with enhanced monitoring (e.g., monitoring for warfarin, therapeutic drug level monitoring for phenytoin)

Exclusion criteria

Exclusion Criteria:

  • The presence of any of the following will exclude a participant from study enrollment.

    • Pulmonary neuroendocrine carcinoma (Small cell or non-small cell) are excluded from this trial.
    • Well differentiated GEP-NETs are excluded from this trial.
    • Prior treatment toxicities that have not resolved to ≤ Grade 2 according to Version 5.0 (list exceptions, e.g. alopecia, neuropathy, etc.).
    • Participants received prior nivolumab or ipilimumab.
    • Participants with untreated /CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with treated CNS metastases will be considered for the study.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to NP-101 or immunotherapy (nivolumab or ipilimumab) used in this study.
    • Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • on an (ECG) corrected for heart rate using Fridericia's formula (QTcF) > 470 ms (males) or > 480 ms (females) at screening (any 2 of 3 triplicate ECGs)
    • Solid organ or hematopoietic stem cell transplant recipients.
    • Participants with significant disease requiring treatment, and participants with active interstitial lung disease or pneumonitis.
    • Participants who have a diagnosis of immunodeficiency or are receiving systemic therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiological doses of corticosteroids may be approved after consultation with the Sponsor. Examples of physiological doses of steroids include: Hydrocortisone: 10-25 mg total daily dose, Prednisone or Prednisolone: 4-10 mg daily, and Methylprednisolone: 3-5 mg daily.
    • Pregnant or breastfeeding women are excluded from this study.
    • Known chronic active untreated or C infection.
    • -positive participants on combination antiretroviral therapy.
    • Participants with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of NP-101 capsules
    • Current use, or use within 14 days prior to first dose (or [5 half-lives / documented induction offset period], whichever is longer), of any strong or moderate inducer of , CYP1A2, CYP2C9, or CYP2D6, including but not limited to those listed in Table 7
    • Current use of any medication that is a sensitive substrate of CYP2C9, CYP3A4, CYP1A2, or CYP2D6 with a narrow therapeutic index (including but not limited to warfarin, phenytoin, and other agents listed in Table 8), unless an alternative non-interacting agent is available, or unless the Investigator/Medical Monitor determines the patient can be safely managed with enhanced monitoring (e.g., monitoring for warfarin, therapeutic drug level monitoring for phenytoin)
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
381 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Other: Placebo · Drug: Ipi/Nivo

  • Experimental
    Low Dose NP-101

    The low dose will be determined during Part I of the study so the actual dosage cannot be specified at the time of posting.

    Drug: NP-101 · Drug: Ipi/Nivo

  • Experimental
    High Dose NP-101

    The high dose will be determined during Part I of the study so the actual dosage cannot be specified at the time of posting.

    Drug: NP-101 · Drug: Ipi/Nivo

Interventions

  • DrugNP-101

    Drug pages: Nigella sativa oil · Black Seed Oil Extract Supplement

    NP-101 is a GMP manufactured enteric capsule containing 600 mg of active pharmaceutical ingredient derived from a botanical source.

  • OtherPlacebo

    A GMP manufactured enteric capsule containing corn oil. Closely matched to NP-101 in size, shape, color and viscosity of API.

  • DrugIpi/Nivo

    Non-experimental treatment intervention for GEP-NEC

06

What researchers measure

Primary outcomes

  1. Part I Primary Safety Objective

    To evaluate the safety of escalating doses of NP-101 combined with Nivo/Ipi. Corresponding Safety Endpoint: Determine incidence of dose-limiting toxicities (DLTs) of NP-101 combined with nivolumab and ipilimumab (Nivo/Ipi) to determine the recommended dose range of NP-101 (dose range of 2 doses will be selected) for study Part 2. Incidence and severity and attribution of adverse events (AEs) and serious adverse events (SAEs), clinical and laboratory, with severity assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

    Time frame: The DLT evaluation period for each participant is the first 28 days

  2. Part I Pharmacokinetic Objective

    To characterize the pharmacokinetic (PK) profile of NP-101 when given alone, and in combination with Nivo/Ipi. Corresponding Pharmacokinetic Endpoint: Serum concentration of thymoquinone at specified timepoints.

    Time frame: PK sampling will occur at various timepoints and frequencies for the first 16 weeks.

  3. Part 2 - Primary Efficacy Objective

    To evaluate and compare the efficacy of 2 doses of NP-101 combined with Nivo/Ipi and select the dose to move forward to Part 3. Corresponding Efficacy Endpoint: Response will be defined by the Objective Response Rate (ORR) at 8 weeks, defined as the percentage of complete responses (CR) or partial responses (PR), as determined by the investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response to treatment in the low and high dose group will be used for dose selection to move forward to Part 3.

    Time frame: Response will be defined by participant response at 8 weeks.

  4. Part 2/Part 3 Primary Efficacy Objective

    Primary Efficacy Objective of Part 2/Part 3: To evaluate the efficacy of the selected dose of NP-101 combined with Nivo/Ipi compared with Placebo combined with Nivo/Ipi. Corresponding Efficacy Endpoint: Overall survival (OS), defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis, or who are lost to follow-up or withdrawn, will be censored at the date they were last known to be alive. Analysis Timepoints: When 130, 195 and 260 Events are observed in the primary analysis populations. Primary analysis participants are those randomized to control or the selected dose across Part 2 (80 participants; 40 of the selected dose and 40 control) and Part 3. A test for superiority of NP-101 arm over the placebo arm will be conducted.

    Time frame: The maximum participation could be up to the final safety follow-up visit which occurs 90 days after last dose. Assuming survival the maximum time could be up to Study Day 821.

  5. Part 2/3 Pharmacokinetic Objective

    To evaluate the efficacy of the selected dose of NP-101 combined with Nivo/Ipi compared with Placebo combined with Nivo/Ipi. Corresponding Secondary Efficacy Endpoint: Serum concentration of thymoquinone at specified timepoints.

    Time frame: Participants in Part 2/3 would participate in the PK sampling until the last day of cycle 4 (Each cycle is 28 days) which for Part2/3 would be Study Day 112

Secondary outcomes

  1. Part 2/Part 3 Secondary Efficacy Objective

    To evaluate the efficacy of the selected dose of NP-101 combined with Nivo/Ipi compared with Placebo combined with Nivo/Ipi. Corresponding Secondary Efficacy endpoint: Objective Response Rate (ORR) defined as the percentage of partial responses \[PR\] and complete responses \[CR\], as determined by the investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The difference in the ORR between the two arms will be calculated. Objective Response Rate (ORR) defined as the percentage of partial responses \[PR\] and complete responses \[CR\], as determined by the BICR according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The difference in the ORR between the two arms will be calculated. Confirmed ORR at week 24, defined as the proportion of participants with BICR confirmed CR or PR as best overall response through Week 24, prior to disease progression, death, or initiation of a new therapy. Progression-free survival (PFS), defined

    Time frame: Week 24

  2. Secondary Objective Part 2/3 Patient Reported Outcomes

    To evaluate patient-reported outcomes (PROs) of disease or treatment-related symptoms, health-related quality of life (HRQoL) and global health status (GHS), and body function, experienced by participants on all treatment arms, as measured by the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC QLQ-C30). To estimate time to deterioration, defined as the time from randomization to first deterioration (decrease from baseline of ≥10 points) in the patient reported HRQoL/GHS and function (physical, role) scales of the EORTC QLQ-C30, maintained for two consecutive assessments or one assessment followed by death from any cause within 3 weeks. The EORTC QLQ-C30 scales and single-item measures convert to scores ranging from 0 (minimum) to 100 (maximum). However, the interpretation of higher scores varies: Global Health Status / Quality of Life: Higher scores indicate better overall quality of life.

    Time frame: From randomization to first deterioration in the patient reported HRQoL/GHS and function (physical, role) scales of the EORTC QLQ-C30, maintained for two consecutive assessments or one assessment followed by death from any cause within 3 weeks.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Nov 13, 2026
StartEst.
Jan 2027
Primary completionEst.
Dec 2029
CompletionEst.
Jun 2031
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935928
Lead sponsor
Novatek Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2029 (estimated)
Completion
Jun 2031 (estimated)
Last update
Nov 13, 2026

Study contacts

Ahmed 0 Kaseb, MD
Contact
akaseb@novatekpharmaceuticals.com
1-877-662-8351
Michelle Y Gocio, BA
Contact
mgocio@novatekpharmaceuticals.com
1-877-662-8351
Ahmed O Kaseb, MD
study chair · Co-Founder, Novatek Pharmaceuticals, Inc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Nigella sativa oil · Black Seed Oil Extract Supplement

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