Advanced Solid and Hematological TP53wt TumorsPhase 1NCT02143635
Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
A Phase 1 study testing HDM201 and ancillary treatment in people with Advanced Solid and Hematological TP53wt Tumors, run by Novartis Pharmaceuticals at 15 sites in 8 countries.
Trial summary
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid and Hematological TP53wt Tumors
- What is being tested?
- HDM201 and ancillary treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 15 sitesin 8 countries
- Study dates
- 7 Jul 2014to 9 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria.
- Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy.
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Prior treatment with compounds with the same mode of action
- Subjects with significant or uncontrolled cardiovascular disease
- History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism
- Previous and concomitant therapy that precludes enrollment, as defined in the protocol
- Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection
- Patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery
Show all 9Show fewer
- Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
- Pregnant or nursing women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
Germany3 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Würzburg, 97080
United States2 sites
Dana Farber Cancer Institute SC-6
Boston, Massachusetts, 02215
Memorial Sloan Kettering Onc. Dep
New York, New York, 10017
France2 sites
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Paris, 75010
Japan2 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Netherlands2 sites
Novartis Investigative Site
Amsterdam, 1066 CX
Novartis Investigative Site
Utrecht, 3584CX
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
About this study
Official title: A Phase I, Open Label, Multicenter, Dose-escalation Study of HDM201 in Adult Patients With Advanced Solid and Hematological Tumors Characterized by Wild-type TP53
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.
- Being tested
- HDM201, ancillary treatment
- Keywords
- HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM201Drug
ancillary treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: HDM201; Drug: ancillary treatment |
| Arm B | Experimental | Not described Receives: Drug: HDM201 |
| Arm C | Experimental | Not described Receives: Drug: HDM201 |
| Arm D | Experimental | Not described Receives: Drug: HDM201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
DLTs in the first cycle of treatment.
Measured: up to 28 days
Secondary outcomes (4)
Number of patients with adverse events (AEs)
Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent.
Measured: For the duration of treatment, an average of 16 weeks
Pharmacokinetics (PK) parameters of HDM201
Measured: Up to 42 days
Changes from baseline of Pharmacodynamics markers
Measured: Baseline, up to 28 days
Tumor response
end of treatment = 1 year
Measured: Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study start7 Jul 2014
- Primary completion20 Jun 2017
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid and Hematological TP53wt TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143635
- Sponsor's protocol ID
- CHDM201X2101
- Status last verified
- May 2021
- First submitted
- 19 May 2014
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multicenter, Dose-escalation Study of HDM201 in Adult Patients With Advanced Solid and Hematological Tumors Characterized by Wild-type TP53
- ClinicalTrials.gov ID
- NCT02143635
- Acronym / sponsor ID
- CHDM201X2101
- Keywords
- HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2014 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: HDM201, Drug: ancillary treatment |
| Arm B | Experimental | Drug: HDM201 |
| Arm C | Experimental | Drug: HDM201 |
| Arm D | Experimental | Drug: HDM201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria.
- Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy.
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (9 listed)
- Prior treatment with compounds with the same mode of action
- Subjects with significant or uncontrolled cardiovascular disease
- History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism
- Previous and concomitant therapy that precludes enrollment, as defined in the protocol
- Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM201 | Drug | Arm A, Arm B, Arm C, Arm D |
| ancillary treatment | Drug | Arm A |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: up to 28 days
DLTs in the first cycle of treatment.
4 secondary outcomes
Number of patients with adverse events (AEs)
Time frame: For the duration of treatment, an average of 16 weeks
Pharmacokinetics (PK) parameters of HDM201
Time frame: Up to 42 days
Changes from baseline of Pharmacodynamics markers
Time frame: Baseline, up to 28 days
Tumor response
Time frame: Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Study ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HDM201 and ancillary treatment in people with Advanced Solid and Hematological TP53wt Tumors, run by Novartis Pharmaceuticals at 15 sites in 8 countries.
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 3 inclusion and 9 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 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, United States, France, Japan, Netherlands and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of dose limiting toxicities (DLTs) (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.