NL-OMON52821招募中2 期
A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 with and without Ruxolitinib in Patients with Myeloproliferative Neoplasms) - Manifest
Constellation Pharmaceuticals0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Phase 2 (MF Expansion - Prior JAKi Arm 1 and Add-on to JAKi Arm 2) Inclusion
- •Patients must meet all of the following criteria to be enrolled in this study:,
- •1. Adult (aged >= 18 years)
- •2. Patients with confirmed diagnosis of MF who meet all of the following
- •a. Dynamic International Prognostic Scoring System (DIPSS) risk category of
- •intermediate-2 or higher.
- •b. Platelet count >= 75 x 10^9 /L without the assistance of thrombopoietic
- •factors or transfusions
- •c. ANC >= 1 x 10^9 /L without the assistance of granulocyte growth factors
- •d. Spleen volume of >= 450 cm^3 by CT or MRI for Cohorts 1B and 2B OR RBC TD
- •transfusions (defined as an average of >= 2 units of RBC transfusions per month
- •[total of >= 6 RBC transfusions over the 12 wks] prior to enrollment) for
- •Cohorts 1A and 2A
- •e. Peripheral blood blast count < 10%
- •f. At least 2 symptoms measurable (score >= 1) using the MFSAF v4.0
- •g. Monotherapy Arm (Arm 1) patients only: Previously treated with a JAKi and be
- •intolerant, resistant, refractory or lost response to the JAKi; have not
- •received the JAKi within 42 weeks prior to start of study drug, or are
- •ineligible to be treated with a JAKi
- •h. Combination Arm (Arm 2) patients only: Must have received ruxolitinib for at
- •least 6 months and be on a stable ruxolitinib dose for a minimum 8 weeks (prior
- •to start of study drug)
- •3. ECOG performance status <= 2
- •4. Serum direct bilirubin <= 1.5 x ULN (upper limit of normal)
- •5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x
- •ULN. The AST and /or ALT may be elevated up to 5 x ULN if the elevation can be
- •reasonably ascribed to liver involvement.
- •6. Calculated or measured creatinine clearance (CrCl) >= 45 ml/min
- •7. Patients must have fully recovered from major surgery and from the acute
- •toxic effects of prior chemotherapy and radiotherapy
- •8. Male and WOBCP and partners of patients with reproductive potential must
- •agree to use highly effective contraceptive methods for 94 days after the last
- •dose of pelabresib for male patients and male partners of female patients and
- •for 184 days after the last dose of study drug for WOCBP and female partners of
- •male patients
- •9. Patients must give written informed consent to participate in this study
- •before the performance of any study-related procedure,
- •Phase 2 (MF Expansion - JAKi Naive Arm 3) Inclusion criteria,
- •Patients must meet all of the following criteria to be enrolled in this study:,
- •1. Adult (aged >= 18 years)
- •2. Patients with confirmed diagnosis of MF who meet all of the following
- •a. DIPSS risk category of intermediate-2 or higher
- •b. Platelet count >= 100 x 10^9 /L without the assistance of thrombopoietic
- •factors or transfusions
- •c. ANC >= 1 x 10^9 /L without the assistance of granulocyte growth factors
- •d. Spleen volume of >= 450 cm^3 by CT/MRI
- •e. Peripheral blood blast count <10%
- •f. At least 2 symptoms measurable (score >= 3) or a total score of >= 10 using
- •the MFSAF v4.0
- •g. No prior treatment with JAKi allowed
- 另有 6 项未显示
排除标准
- •Phase 2 (MF Expansion - Prior JAKi Arm 1 and Add-on to JAKi Arm 2) Exclusion
- •Patients who meet any of the following criteria will not be enrolled in the
- •1. Patients in Cohorts 1B and 2B only: Patients who have had prior splenectomy
- •2. Patients in Cohorts 1B and 2B only: Patients who have had splenic
- •irradiation within 3 months of starting study drug
- •3. Current known active or chronic infection with human immunodeficiency virus
- •(HIV), Hepatitis B or Hepatitis C.
- •4. Patients with active clinically significant infection will not be eligible
- •for enrollment until
- •recovery for at least 2 weeks prior to the first dose of study drug.
- •5. Patients with anemia from iron deficiency, B12 and folate deficiencies,
- •hemolytic anemia, or
- •6. Serum ferritin level < lower limit of normal (LLN) as per institutional
- •7. Patient with a major bleeding event causing a decrease in hemoglobin of >=
- •2g/dL or leading to transfusion of >= 2 units of packed red cells in the last 6
- •months prior to enrollment.
- •8. Patients with Child-Pugh Class B or C
- •9. Impairment of GI function or GI disease that could significantly alter the
- •absorption of CPI-0610 and/or ruxolitinib, including any unresolved nausea,
- •vomiting, or diarrhea > CTCAE grade 1
- •10. Impaired cardiac function or clinically significant cardiac diseases,
- •including any of the
- •a. Acute myocardial infarction or unstable angina pectoris <= 6 months prior to
- •starting study drug
- •b. QTcF > 500 msec on the screening ECG
- •c. Uncontrolled clinically significant cardiac arrhythmia
- •11. Ongoing uncontrolled hypertension despite maximal antihypertensive treatment
- •12. Any other concurrent severe and/or uncontrolled concomitant medical
- •condition that in the opinion of the investigator could compromise
- •participation in the study or analysis of study data.
- •13. Systemic anti-cancer treatment (other than ruxolitinib for the Combination
- •Arm [Arm 2]; see inclusion criterion #2) other than hydroxyurea and anagrelide
- •less than 2 weeks (or 5 half-lives, whichever is longer) before the first dose
- •of CPI-0610.
- •14. Any investigational agent less than 2 weeks (or 5 halflives, whichever is
- •longer) before the first dose of CPI-0610
- •15. Prior treatment with a BET inhibitor
- •16. Hematopoietic growth factor (granulocyte growth factor, erythropoiesis
- •stimulating agent, thrombopoietin mimetic) or androgenic steroids less than 4
- •weeks before the first dose of study drug
- •17. Patients in the Combination Arm (Arm 2) who are receiving treatment with
- •fluconazole.
- •18. Systemic corticosteroids at daily doses >= 10 mg of oral prednisone or
- •equivalent within 2 weeks before the first dose of study drug.
- •19. Women who are lactating or pregnant females as documented by a serum beta
- •human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy,
- •obtained within 72 hours prior to the first dose of CPI-0610.
- •20. Patients unwilling or unable to comply with this study protocol
- •Phase 2 (MF Expansion - JAKi Naive Arm 3) Exclusion criteria
- •Patients who meet any of the following criteria will not be enrolled in the
- 另有 3 项未显示
研究者
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