Status:
WITHDRAWN
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies
Lead Sponsor:
Erasca, Inc.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
* To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies. * To determine the...
Detailed Description
This is a Phase 1b/2, open-label, multicenter master protocol evaluating safety, tolerability, and preliminary efficacy of ERAS-007 or ERAS-601 in combination with other cancer therapies in study part...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Willing and able to give written informed consent.
- Diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization classification.
- Relapsed after or refractory to first-line AML therapy.
- Positive for FLT3 mutation in bone marrow or whole blood.
- Eastern Cooperative Oncology Group performance status ≤ 2 with no deterioration during screening period.
- Adequate hepatic and renal function.
- Recovery from non-hematologic AEs associated with prior therapy to baseline CTCAE v5 Grade 0 or 1, except for AEs not considered a safety risk (eg, alopecia or vitiligo).
- Able to take oral medication with no medical conditions that prevent swallowing and absorbing oral medications.
- Willing to comply with all protocol-required visits, assessments, and procedures.
Exclusion
- Diagnosis of AML secondary to prior chemotherapy or other neoplasms (except for MDS).
- Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia (chronic myeologenous leukemia in blast crisis).
- Clinically active central nervous system leukemia.
- Second or later hematologic relapse or prior salvage therapy for refractory disease.
- For participants being considered for ERAS-007+gilteritinib treatment: prior therapy with ERK inhibitor.
- For participants being considered for ERAS-601+gilteritinib treatment: prior therapy with SHP2 inhibitor.
- Anticancer therapy ≤14 days prior to first dose (except hydroxyurea given for controlling blast count), or ≤5 half-lives prior to first dose, whichever is shorter.
- Palliative radiation ≤7 days prior to first dose.
- Major surgery within 28 days of enrollment.
- Contraindication to gilteritinib use as per local label.
- Known hypersensitivity to any of the components of ERAS-007 or ERAS-601.
- Clinically active infection, requiring systemic therapy.
- Impaired cardiovascular function or clinically significant cardiovascular disease.
- History of thromboembolic or cerebrovascular events ≤6 months prior to first dose.
- History of other malignancy ≤3 years prior to first dose.
- History of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or risk factors to RPED or RVO.
- History of or clinically active interstitial lung disease (ILD), drug induced ILD, or radiation pneumonitis that required steroid treatment.
- Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the participant inappropriate to participate in the study.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05279859
Start Date
March 15 2022
End Date
June 1 2025
Last Update
June 15 2022
Active Locations (4)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Texas Oncology
Dallas, Texas, United States, 75251
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031