EUCTR2018-000125-30-GBActive, not recruitingPhase 1
An Open-Label Phase 2 Study to Evaluate PT2977 for the Treatment of von Hippel-Lindau Disease-Associated Renal Cell Carcinoma - Phase 2 Study of PT2977 for Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma
Peloton Therapeutics, Inc., a Wholly-Owned Subsidiary of Merck & Co., Inc.0 sites61 target enrollmentStarted: March 13, 2018Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 61
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Has the ability to understand and willingness to sign a written
- •informed consent form before the performance of any study-specific
- •2. 18 years of age or older
- •3. Has a diagnosis of von Hippel-Lindau disease, based on a germline VHL alteration.
- •4. Has at least 1 measurable solid RCC tumor and no RCC tumor greater
- •than 3.0 cm that requires immediate surgical intervention. The diagnosis
- •of RCC can be radiologic (histologic diagnosis not required). Patients
- •may have VHL disease-associated tumors in other organ systems
- •5. Has an Eastern Cooperative Oncology Group (ECOG) performance
- •status of 0 to 1
- •6. Has organ and marrow function as defined below:
- •Absolute neutrophil count = 1,000/µL, hemoglobin level = 10 g/dL and
- •platelet count = 100,000/µL without transfusion or growth factor
- •support within 2 weeks prior to obtaining the hematology values at
- •Serum creatinine level = 2.0 × upper limit of normal (ULN)
- •AST and ALT < 2.5 × ULN, total bilirubin < 1.5 × ULN (< 3 × ULN in
- •patients with Gilbert's disease), and alkaline phosphatase = 2.5 × ULN
- •7. Male participants are eligible to participate if they agree to the
- •following during the intervention period and for at least 5 days after the
- •last dose of study intervention:
- •Be abstinent from heterosexual intercourse as their preferred and
- •usual lifestyle (abstinent on a long term and persistent basis) and agree
- •to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic
- •(vasectomized or secondary to medical cause [Appendix 2]) as detailed
- •- Agree to use a male condom plus partner use of an additional
- •contraceptive method when having penile-vaginal intercourse with a
- •WOCBP who is not currently pregnant. Note: Men with a pregnant or
- •breastfeeding partner must agree to remain abstinent from penilevaginal
- •intercourse or use a male condom during each episode of penilevaginal
- •penetration.
- •Male participants must also agree to use male condom when engaging
- •in any activity that allows for passage of ejaculate to another person of
- •Contraceptive use by men should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •8. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and using a contraceptive method that is highly effective
- •(with a failure rate of <1% per year), with low user dependency, or be
- •abstinent from heterosexual intercourse as their preferred and usual
- •lifestyle (abstinent on a long term and persistent basis), as described in
- •Appendix [2] during the intervention period and for at least 30 days
- •after the last dose of study intervention. The investigator should
- •evaluate the potential for contraceptive method failure (ie,
- •noncompliance, recently initiated) in relationship to the first dose of
- •study intervention.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine
- •or serum as required by local regulations) within 24 hours before the
- •first dose of study intervention.
- +7 more not shown
Exclusion Criteria
- •1. Has participated in another clinical trial of an investigational drug (or a medical device) within 30 days of study enrollment
- •2. Has received prior treatment with PT2977 or another HIF-2a inhibitor
- •3. Has had any systemic anti-cancer therapy (includes anti-VEGF therapy or any systemic investigational anti-cancer agent)
- •4. Has had radiotherapy within 4 weeks prior to study enrollment
- •5. Has had surgical procedure for VHL disease or any major surgical procedure completed within 4 weeks prior to study enrollment
- •6. Has an immediate need for surgical intervention for tumor treatment
- •7. Has a prior or concomitant non-VHL disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the patient has remained disease free for more than 2 years
- •8. Evidence of metastatic disease on screening imaging.
- •9. Has malabsorption due to prior gastrointestinal (GI) surgery or GI disease
- •10. Has hypersensitivity to the active pharmaceutical ingredient or any component in the formulation
- •11. Has an active infection requiring systemic treatment
- •12. Has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event, pulmonary embolism, clinically significant ventricular arrhythmias
- •(e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure
- •13. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
- •14. If a female patient, intends to breast feed a child while on study drug or within 30 days after administration of the last dose of study drug.
- •15. A WOCBP who has a positive urine pregnancy test within 24 hours
- •prior to the first dose of study intervention (see Appendix 2). If the urine
- •test is positive or cannot be confirmed as negative, a serum pregnancy
- •test will be required.
- •16. Adults without legal capacity, under guardianship or curatorship,
- •deprived of their liberty.
Investigators
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