New study checks cancer Drug's effect on common medications
NCT ID NCT07340190
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times
Summary
This study looks at how a cancer drug called pelabresib changes the way the body processes three other medicines: repaglinide (for diabetes), midazolam (a sedative), and a birth control pill. It involves 24 adults with advanced cancers who have no standard treatment options. The goal is to gather information for safer drug use, not to treat the cancer itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Apr 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: Key inclusion criteria for all participants (Arm A and Arm B) * Is at least 18 years of age at the time of signing the informed consent. * Has a confirmed documented diagnosis of an advanced malignancy for which no standard and/or curative treatment options are available * Has the following acceptable laboratory assessments prior to the first dose of study treatment: 1. Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment 2. Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors 3. Peripheral blood blast count \< 5%. Assessment of blasts in bone marrow is not mandatory at screening; however, blasts must be \<5% if the bone marrow assessment is performed. 4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤5 × ULN if the elevation can be ascribed to liver involvement) 6. Calculated or measured creatinine clearance of ≥30 mL/min\* * Has fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy (residual Grade 1 toxicities and residual alopecia of any grade are allowed). Additional inclusion criterion for Arm B • Is a female participant. Key Exclusion Criteria: Key exclusion criteria for Arm A * Has a history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class. * Is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding. * Has current known active or chronic infection with HIV, hepatitis B, or hepatitis C. * Has impaired cardiac function or clinically significant cardiac disease. * Has a gastrointestinal tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the gastrointestinal tract that could alter the absorption of pelabresib, midazolam, or repaglinide, including any unresolved nausea, vomiting, or diarrhea. Key exclusion criteria for Arm B * Has renal impairment (CrCl less than 50 mL/min). * Has a gastrointestinal tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the gastrointestinal tract that could alter the absorption of pelabresib, drospirenone and ethinyl estradiol, including any unresolved nausea, vomiting, or diarrhea. * Has breast cancer or other estrogen- or progestin-sensitive cancer. * Has undiagnosed abnormal uterine bleeding. Other protocol-defined inclusion/exclusion criteria may apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced malignancies are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
6 sites in 3 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Novartis Investigative Site
RECRUITINGBordeaux, 33075, France
-
Novartis Investigative Site
RECRUITINGCandiolo, TO, 10060, Italy
-
Novartis Investigative Site
RECRUITINGPozuelo de Alarcón, Madrid, 28223, Spain
-
Novartis Investigative Site
RECRUITINGBarcelona, 08023, Spain
-
Novartis Investigative Site
RECRUITINGMadrid, 28040, Spain
-
Novartis Investigative Site
RECRUITINGMadrid, 28050, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a smart drug deliver a toxic payload directly to cancer cells?
- Cancer drug pralsetinib may change how the body processes other medications
- New drug combo aims to boost immune attack on Hard-to-Treat cancers
- New drug combo shows promise for tough cancers
- Cancer drug pelabresib gets Long-Term safety check in extension trial
- New taxane drug RP-001 enters human trials for Hard-to-Treat cancers