Neoplasms

Blood and Lymph Conditions

All Conditions

Digestive System Diseases

Hematologic Neoplasms

Liver Diseases

Gastrointestinal Diseases

Each healthy participant will receive a single dose of HDM201

Each participant with mild Child-Pugh will receive a single dose of HDM201

Each participant with moderate Child-Pugh will receive a single dose of HDM201

Each participant with severe Child-Pugh will receive a single dose of HDM201

Siremadlin

Novartis Pharmaceuticals

The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose. In addition, safety and tolerability of siremadlin after a single oral dose will be evaluated. The results of this study will inform the decision whether a dose adjustment may be recommended when treating patients with various degrees of impaired hepatic function.

Participants will be recruited into one of 4 groups according to the Child-Pugh classification score. Participants with HI will be enrolled into either mild (Child-Pugh A; Group 2), moderate (Child Pugh B; Group 3) or severe (Child-Pugh C; Group 4) HI groups. Healthy control participants (Group 1) will be matched to 1 or more participants with HI with respect to age (± 10 years), body weight (± 20%) and sex. Each participant in the matched healthy control group (Group 1) can be matched to participant(s) in any HI group (Groups 2, 3, and 4).

The study will enroll the four groups in parallel. Therefore, enrollment in Group 1 will remain open until enrollment in the mild, moderate and severe HI groups is complete and each HI participant has a matched healthy control (Group 1) participant. Participants from Group 1 will be enrolled after at least 3 participants from each of Groups 2 and 3 have completed all scheduled assessments.

The study consists of a screening period of up to 28 days (Days -29 to -2), a baseline evaluation on Day -1, a single dose administration of siremadlin on Day 1 followed by PK sampling up to 144 hours post-dose (Day 7). All baseline safety evaluation results must be available and reviewed prior to the dosing. All eligible participants will be domiciled from Day -1 until Day 7.

Safety assessments will include physical examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, urinalysis, coagulation), AE and serious adverse event (SAE) monitoring.

All participants will have a post-study safety follow-up contact conducted approximately 30 days after administration of study treatment. The study will be considered complete once all the participants have finished the required assessments, dropped out, or been lost to follow-up before completing the required assessments.

The total study duration for each participant is expected to be up to maximum of 59 days, including the Screening period and the 30-day post-study safety contact follow up period.

Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment

A Phase 1, Open-label, Multi-center, Single-dose, Parallel Group Study to Evaluate the Pharmacokinetics of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment Compared to Matched Healthy Control Participants

Maximum Observed Blood Concentrations (Cmax) for siremadlin. Blood samples will be collected to measure Cmax at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Area Under Plasma Concentration-time Curve from time zero to the last measurable concentration sampling time (AUClast) for siremadlin. Blood samples will be collected to measure AUClast at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Area Under Plasma Concentration from time zero to time "t" (AUC0-t). The definition of "t" may be data driven post-hoc to mitigate bias in the exposure comparision due to between-group differences in Tlast for siremadlin. Blood samples will be collected to measure AUC0-t at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Area Under Plasma Concentration from time zero to 24-hour post-dose sampling time (AUC0-24h) for siremadlin. Blood samples will be collected to measure AUC0-24h at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Last measurable plasma concentration (Tlast) for siremadlin. Blood samples will be collected to measure Tlast at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Time to Reach Maximum Blood Concentrations (Tmax) for siremadlin. Blood samples will be collected to measure Tmax at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Apparent total body clearance of siremadlin from plasma (CL/F). Blood samples will be collected to measure CL/F at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Apparent volume of distribution during terminal elimination phase (Vz/F) of siremadlin. Blood samples will be collected to estimate Vz/F at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Terminal Elimination Half-life (T1/2) for siremadlin. Blood samples will be collected to measure T1/2 at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Area Under Plasma Concentration from time zero to infinity (AUCinf). Blood samples will be collected to measure AUCinf at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Venetoclax

Azacitidine

Antimetabolites

Enzyme Inhibitors

Unfit adult participants with AML who responded sub-optimally to at least 2 and not more than 4 cycles ( 1 cycle=28 days) of first-line venetoclax plus azacitidine therapy

Unfit adult participants with newly diagnosed AML and with adverse genetic risk stratification (according to ELN 2022)(Except TP53 mutation positive participants).

Siremadlin is a capsule taken orally once a day (QD) and comes in 10 mg, 20 mg and 30 mg strengths

siremadlin

Venetoclax is a tablet taken orally once a day (QD) and comes in 10 mg, 50 mg and 100 mg strengths.

venetoclax

Azacitidine is a powder for suspension for injection or powder for solution for infusion taken intravenously or subcutaneously according to standard local clinical practice

azacitidine

A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy.

The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML patients without unacceptable levels of treatment-emergent toxicities.

The recommended dose of siremadlin in combination with venetoclax plus azacitidine will be determined to be explored further in the expansion phase and the preliminary efficacy in achieving Complete Remission (CR) will be evaluated in participants who responded sub-optimally to first-line venetoclax plus azacitidine treatment.

The study was planned to be conducted in two parts. The primary purpose of Part 1 (Safety Run- in) was to rule out excessive toxicity of siremadlin when administered in combination with venetoclax plus azacitidine while the primary purpose of Part 2 (Expansion) was to evaluate the preliminary efficacy of siremadlin when combined with venetoclax plus azacitidine in the respective patient population.

The study treatment (siremadlin in combination with venetoclax plus azacitidine) is administered in cycles with a planned duration of 28 days and will continue until the participants experience disease progression/relapse or unacceptable toxicity.

The initial enrollment plan and safety review was as follow:

* In the Safety run-in part, 9-15 participants were planned to be enrolled in each arm. Approximately 3-6 participants were planned to be enrolled at the starting dose level of siremadlin in combination with venetoclax plus azacitidine in both arms independently. Provided the starting dose level is determined to be safe, approximately 6-9 additional participants were planned to be enrolled at dose level +1. Safety review meetings were planned to take place involving participating investigators and the Sponsor Team to make decisions regarding siremadlin dose and determine the recommended dose for expansion.
* Approximately 26 patients were planned to be treated at the recommended dose in the expansion part.

In the safety run-(Part 1) 27 sites were open for recruitment with 28 patients screened and 14 patients enrolled.

After enrolling 14 patients (6 patients in Arm 1 and 8 patients in Arm 2), Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program. For that reason, the enrollment in Part 2 (expansion phase) will not be open. The Novartis decision was not driven by any safety concerns.

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

A Phase Ib/II Open Label Dose Confirmation, Proof of Concept Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Unfit Adult AML Participants Who Responded Sub-optimally to First-line Venetoclax Plus Azacitidine Treatment and in Participants With Newly Diagnosed Unfit AML Presenting With High-risk Clinical Features

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

The objective for the safety run-in is to determine the recommended dose of siremadlin in combination with venetoclax plus azacitidine to be explored further in the expansion part separately in Arm 1 and Arm 2.

The objective is to evaluate preliminary efficacy of siremadlin at the determined recommended dose for expansion (RDE) when administered in combination with venetoclax and azacitidine.

This endpoint will not be analyzed since the recommended dose was not determined due to early termination.

Assessment of CR in order to evaluate preliminary efficacy of siremadlin (in combination of venetoclax plus azacitidine) at the determined recommended dose for Arm 2 participants.

This endpoint will not be analyzed since the recommended dose was not determined due to early termination.

Assessment of duration of CR in participants who achieved a CR.

This endpoint will not be analyzed since the recommended dose was not determined due to early termination.

Assessment of CR/CRh rate and CR/CRi rate.

Assessment of duration of CR/CRh and duration of CR/CRi.

This endpoint will not be analyzed since the recommended dose was not determined due to early termination.

Assessment of Overall Survival (OS).

This endpoint will not be analyzed since the recommended dose was not determined due to early termination.

To assess rate of early mortality at 30 day and 60 days from start of study treatment

AUC0-t: The area under the concentration vs. time Curve (AUC) from time zero to specified time point.

AUClast is the AUC from time zero to the last quantifiable concentration point (last) (mass x time x volume -1).

AUCtau is the AUC to the end of the dosing interval as when possible PK samples will be collected up to 24 h postdose for siremadlin and venetoclax. Steady-state will be assumed on Day 5 (AUCtau, ss) in case of continuous dosing.

To characterize the PK of siremadlin, venetoclax and azacitidine administered in combination in each arm. Cmax is the maximum (peak) observed plasma, blood, serum or other body fluid drug concentration following drug administration (mass x volume -1)

PK parameter Tmax and concentration vs time profiles of siremadlin, venetoclax and azacitidine. Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after drug administration (time).

To assess the effect of siremadlin in combination with venetoclax plus azacitidine in MRD

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Carcinoma

Lung Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Anti-Infective Agents

Antibodies

Everolimus

Immunoglobulins

Panobinostat

Spartalizumab

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Immunosuppressive Agents

Immunologic Factors

Histone Deacetylase Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Enrollment to this combination arm is closed to further enrollment.

Dose escalation completed, expansion arm.

PDR001

LCL161

QBM076

HDM201

The purpose of this study was to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With LCL161, Everolimus (RAD001) or Panobinostat (LBH589)

During the first two cycles Cycle = 28 days

Through study completion, an average of 6 months

Baseline and end of treatment, an average of 6 months

Cycle 1 through cycle 6 in treatment period 1, an average of 6 months

Cycle 1 through cycle 6 in treatment period 1 and 2, an average of 6 months

Symptoms and General Pathology

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Trametinib

* HDM201: Therapeutic class HDM2 inhibitor, given Per Os every D1 and D8 over a 28 day cycle. Four dose-levels possible in dose escalation part: 40 mg, 80mg, 100 mg, 120mg.
* Trametinib: Therapeutic class Protein kinase inhibitor of MEK1 and MEK2 activation and kinase activity. Administrated daily, countinous dosing , twodose-level possible in dose escalation: 1.5 mg and 2mg

Treatment will be administered as long as patient experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

Philippe CASSIER, MD

Recent preclinical studies suggest that combining MEK and MDM2 inhibition synergize to induce apoptosis in RAS/BRAF-mutant and TP53 wild-type CRC models. In vitro, in RKO cell lines (poorly differentiated colon carcinoma cell line resistant to single agent targeting MDM2 and MEK and BRAF inhibition), the MDM2 plus MEK inhibitor combination generated a synergistic increase in apoptotic index. In vivo, in mice harboring human RKO colon tumor xenografts the combination of MDM2 plus MEK inhibition elicited 93% decreases in tumor volume.

This trial is to conduct a single-center, Phase 1 dose escalation study of trametinib combined with HDM201 (a HDM2 inhibitor) in patients with advanced/metastatic RAS/RAF mutant and TP53 wt CRC.

This trial is a Phase I dose escalation study aiming to evaluate the safety of a combined treatment associating HDM201 (escalating doses) with Trametinib (fixed dose). This study will utilize sequential and adaptive Bayesian design using the method of Time-to-event Continual Reassessment Method (CRM) to guide dose escalation and estimate the MTD.

This study will utilize sequential and adaptive Bayesian design using the method of Time-to-event Continual Reassessment Method (CRM) to guide dose escalation and estimate the MTD

Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

A Single-center, Phase 1 Dose Escalation Study of Trametinib Combined With HDM201 in Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer.

A DLT is defined as occurring during the first 2 cycles of treatment and considered by the Investigator to be clinically significant and related to study drugs HDM201 and/or Trametinib, and including: Non-hematological AE as follows (Grade ≥4 non-laboratory toxicity) Grade ≥3 non-laboratory toxicity lasting \> 7 days despite optimal supportive care; Any Grade ≥3 laboratory value if (Medical intervention is required to treat the patient, or, The abnormality leads to hospitalization, or The abnormality persists for \> 7 days) Hematological AE as follows (Grade 4 toxicity lasting ≥ 7 days, or, Grade ≥ 3 thrombocytopenia if associated with bleeding and requires platelet transfusion, or Febrile neutropenia Grade 3 or Grade 4) Any Grade 5 related to study drugs.

Any other study drugs related AE considered significant enough to be qualified as DLT in the opinion of the investigators after discussion with the Sponsor.

The objective response rate (ORR) after 8 weeks of treatment will be defined as the proportion of patients with complete response (CR) or partial response (PR). It will be described on the efficacy-evaluable population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1.

The objective response rate (ORR) after 16 weeks of treatment will be defined as the proportion of patients with complete response (CR) or partial response (PR). It will be described on the efficacy-evaluable population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1.

The duration of response (DoR) will be measured from the time of first documented response (CR or PR as per RECIST 1.1) until the first documented disease progression or death due to underlying cancer, or censored at the date of the last available tumor assessment.

after 8 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1.

after 16 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1.

will be measured from C1D1 until the date of event defined as the first documented progression or death from any cause. Patients with no event at the time of the analysis will be censored at the date of the last available tumor assessment. PFS will be estimated using the Kaplan-Meier method.

Novartis

Centre Leon Berard

Liposarcoma

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

LEE011

To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.

Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma

To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Run-in part to assess safety of HDM201 in combination with LEE011

Run-in part To assess tolerability of HDM201 in combination with LEE011

Run-in part to evaluate PK parameters of HDM201 and LEE011

Run-in part to evaluate the PK parameters of HDM201 and LEE011

Run-in part measure of GDF-15 fold-change in protein levels (PD direct targets of p53) to assess PD changes from baseline in blood and a potential relationship with clinical outcome.

Run-in part measure of p21 and MDM2 protein levels by IHC (H-Score) (p53 and CDK4 pathways) to assess changes from baseline of PD markers in tumor tissue and a potential relationship with clinical outcome.

Run-in part to assess PD effect of HDM201 and LEE011 and a potential relationship with clinical outcome

Run-in part to assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Run-in part to further assess the anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

The aim of each extension cohort is to provide preliminary evidence of anti-tumor activity while refining toxicity data, and to gain insight progressive disease activity and exploratory biological analyses. A maximum of 14 patients patients will be enrolled in this cohort " Soft-tissue sarcomas with MDM2 amplification ". Both study drugs (pazopanib and HDM201) will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

A maximum of 14 patients patients will be enrolled in this cohort " Soft-tissue sarcomas with no MDM2 amplification". Both study drugs (pazopanib and HDM201) will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

Part 1: A dose escalation part with the aim to assess the safety of the proposed combination. Eligible patients will be treated with a fixed dose of pazopanib (800mg/d, continuously) and escalating doses of HDM201. Both study drugs will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression or withdrawal of consent.

Part 2: An extension part with a fixed dose of pazopanib (800mg/d, continuously) and the recommended phase 2 dose of HDM201 determined during the dose escalation part. Both study drugs will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression or withdrawal of consent.

Pazopanib

Jean-Yves BLAY, MD

Mariella SPALATO CERUSO, MD

Antoine ITALIANO, MD

Coriolan LEBRETON, MD

Florent PEYRAUD, MD

Maud TOULMONDE, MD

Medhi BRAHMI, MD

Lucas DE CRIGNIS, MD

Brunhilde HANVIC, MD

Aurélie SWALDUZ, MD

Armelle VINCENEUX, MD

Hélène VANACKER, MD

Loic VERLINGUE, MD

Catherine TERRET, MD

Thibaud VALENTIN, MD

Carlos-Alberto GOMEZ-ROCA, MD

Iphigénie KORAKIS, MD

This trial is a two-step Phase I/II study comprising:

Part 1: A dose escalation part with the aim to assess the safety of the proposed combination (N= up to 30 patients). In the dose escalation part, eligible patients will be treated with a fixed dose of pazopanib and escalating doses of HDM201.

Part 2: An extension part to collect preliminary data about the clinical activity of the proposed combination according to the 6M-PFR.

This trial is a two-step Phase I/II study comprising:

Part 1: A dose escalation part with the aim to assess the safety of the proposed combination (N= up to 30 patients). The dose escalation will be conducted according to a sequential and adaptive Bayesian scheme using the method of Time-to-event Continual Reassessment Method (CRM) to guide dose escalation and estimate the Maximum Tolerated Dose.

In the dose escalation part, eligible patients will be treated with a fixed dose of pazopanib (800 mg/d) and escalating doses of HDM201: 60 mg (starting dose); 80 mg; 100 mg; 120 mg. For a safety reason, a dose level of 40 mg is included in case that the first dose level is found to be toxic. In addition, decrease of pazopanib dosing to 600 mg/d could be appropriate following protocol amendment.

To ensure adequate patient safety during the dose escalation part, there will be a 3-day delay between the first and subsequent patients enrolled in each DL cohort to maximize the safety of enrolled patients.

No intra-patient dose escalation is allowed.

Part 2: An extension part to collect preliminary data about the clinical activity of the proposed combination according to the 6 months Progression Free Rate (6M-PFR).

The dose escalation will be conducted according to a sequential and adaptive Bayesian scheme, using the method of TITE-CRM to determine the MTD of pazopanib in combination with HDM201. This method allows continual accrual (i.e. the study will be opened to accrual continually) throughout the trial while using the 6-week toxicity endpoint as basis of dose escalation.

Dose allocation will be centrally defined, before each inclusion considering the DLT observed in all patients previously evaluated, and the current toxicity status of patients who have not received a full 2-cycle treatment (i.e. DLT period is still ongoing).

* A cumulative experience of 4 cycles at a given DL is required before allowing dose escalation to the next DL. Cumulative experience is defined as the addition of observation periods of all included and treated patients.
* A maximum of 6 patients can be included and treated at a same dose level before reassessment occurred.

HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas

A Multicenter, Phase I/II Study Evaluating the Clinical Impact of HDM201 + Pazopanib in Patients With P53 Wild-type Advanced/ Metastatic Soft Tissue Sarcomas (AMPHISARC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment	NCT05599932	Hepatic Impairm...	Siremadlin	18 Years - 75 Years	Novartis
A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.	NCT05155709	Acute Myeloid L...	siremadlin venetoclax azacitidine	18 Years - 99 Years	Novartis
A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat	NCT02890069	Colorectal Canc...	PDR001 LCL161 Everolimus Panobinostat QBM076 HDM201	18 Years -	Novartis
A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat	NCT02890069	Colorectal Canc...	PDR001 LCL161 Everolimus Panobinostat QBM076 HDM201	18 Years -	Novartis
Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type	NCT03714958	Colorectal Canc... Advanced Cancer Metastatic Canc...	HDM201 Trametinib	18 Years -	Centre Leon Berard
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma	NCT02343172	Liposarcoma	HDM201 LEE011	18 Years -	Novartis
HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas	NCT05180695	Advanced Soft-t... Metastatic Soft...	Pazopanib HDM201	18 Years -	Centre Leon Berard
HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas	NCT05180695	Advanced Soft-t... Metastatic Soft...	Pazopanib HDM201	18 Years -	Centre Leon Berard
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma	NCT02343172	Liposarcoma	HDM201 LEE011	18 Years -	Novartis
A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat	NCT02890069	Colorectal Canc...	PDR001 LCL161 Everolimus Panobinostat QBM076 HDM201	18 Years -	Novartis
A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma.	NCT02601378	Uveal Melanoma	LXS196 LXS196 and HDM2...	18 Years -	Novartis
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma	NCT02343172	Liposarcoma	HDM201 LEE011	18 Years -	Novartis

Spots Global Cancer Trial Database for hdm201

Every month we try and update this database with for hdm201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hdm201

Every month we try and update this database with for hdm201 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hdm201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.