Pelabresib drug interactions with common meds in advanced cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study assesses the potential drug-drug interactions between pelabresib and three sets of medications: repaglinide and midazolam, and a combined oral contraceptive (drospirenone/ethinyl estradiol). Participants receive pelabresib at steady state while a single dose of each victim drug is administered to evaluate changes in pharmacokinetics. The trial is conducted in two parts, with hospitalization for close monitoring during DDI assessment and potential continuation in additional cycles for those who benefit. Safety follow-up continues after treatment completion, with hematologic malignancy patients followed every 3 months thereafter.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Bordeaux, France Recruiting
• Novartis Investigative Site
  Candiolo, To, Italy Recruiting
• Novartis Investigative Site
  Pozuelo de Alarcón, Madrid, Spain Recruiting
• Novartis Investigative Site
  Barcelona, Spain Recruiting
• Novartis Investigative Site
  Madrid, Spain Recruiting
• Novartis Investigative Site
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GPC3-targeted ADC for advanced solid tumors

  This early-phase trial tests a Glypican-3 targeted antibody-drug conjugate (TQB6426) in adults with advanced cancers to see if it is safe and tolerable and to explore potential anti-tumor activity.

  Recruiting Phase 1 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Hefei, Anhui and 7 other locations · NCT07730190

• Pralsetinib Drug Interaction Study in RET Fusion/MUTATION Positive Solid Tumors

  This trial tests whether pralsetinib changes how the body processes certain medicines in adults with RET fusion- or mutation-positive advanced solid tumors.

  Recruiting at 2 sites Phase 4 Rigel Pharmaceuticals · Logroño, La Rioja and 1 other locations · NCT07704658

• PM54 plus immunotherapy in adults with advanced cancer

  This trial tests PM54 together with pembrolizumab to see if it is safe and tolerable and to see if it helps shrink or stabilize tumors in adults with advanced cancers.

  Recruiting at 11 sites Phase 1/2 PharmaMar · New York, New York and 10 other locations · NCT07644039

• PF-07994525 in advanced cancers: a first-in-human dose-escalation study

  A single-arm, early-phase study tests PF-07994525 in adults with advanced cancers who have exhausted other therapies to see if it’s safe and shows any signs of tumor activity.

  Recruiting at 29 sites Phase 1 Pfizer · Denver, Colorado and 29 other locations · NCT07426757

• BR111-101 treatment for advanced cancers

  This Phase 1 test will try BR111-101 injections in adults with advanced solid tumors or relapsed/refractory B-cell lymphoma who have run out of or cannot tolerate standard treatments.

  Recruiting Phase 1 BioRay Pharmaceutical Co., Ltd. · Shanghai, Pudong New Area · NCT06937957

• Combining IBI363 with Bevacizumab or Furuitinib for Advanced Colorectal Cancer

  This study is testing if a new drug called IBI363, when combined with either Bevacizumab or Furuitinib, can help adults with advanced colorectal cancer who haven't responded to standard treatments.

  Recruiting Phase 1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT06717880

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.