A Study of CA-4948 in Patients With Relapsed or Refractory Hematologic Malignancies
Status: | Recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/23/2019 |
Start Date: | December 28, 2017 |
End Date: | December 2021 |
Contact: | Robert Martell, MD |
Email: | clinicaltrials@curis.com |
Phone: | 617-503-6500 |
An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Hematologic Malignancies
This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult
patients with Relapsed or Refractory Hematologic Malignancies. The trial will be conducted in
2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or
Refractory Hematologic Malignancies, and a Dose Expansion Phase (Part B) of CA-4948 in
patients with selected RR hematologic malignancies (including NHL with and without myeloid
differentiation primary response 88 (MYD88) mutations, and AML).
patients with Relapsed or Refractory Hematologic Malignancies. The trial will be conducted in
2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or
Refractory Hematologic Malignancies, and a Dose Expansion Phase (Part B) of CA-4948 in
patients with selected RR hematologic malignancies (including NHL with and without myeloid
differentiation primary response 88 (MYD88) mutations, and AML).
Inclusion Criteria:
1. Males and females greater than or equal to 18 years of age
2. Life expectancy of at least 3 months
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
4. Diagnosis of histopathologically confirmed hematologic malignancies. For NHL:
Confirmed B-cell NHL (as per the World Health Organization [WHO] 2016 classification
including WM/LPL). For AML: Diagnosis of histopathologically confirmed AML (as per the
World Health Organization [WHO] 2016 classification; Owen 2013) that is relapsed
and/or refractory.
5. Relapsed or refractory disease for which patients are ineligible for or have exhausted
standard therapeutic options that would be considered standard of care
Exclusion Criteria:
1. Active central nervous system (CNS) involvement of their malignancy.
2. Radiotherapy delivered to non-target lesions within one week prior to starting study
treatment or delivered to target lesions that will be followed on the study (NOTE:
prior sites of radiation will be recorded)
3. History of allogeneic stem cell transplant for NHL
4. Any prior anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy,
etc., received within 14 days prior to start of CA-4948
5. Current or planned glucocorticoid therapy, with the following exceptions:
1. Doses ≤ 10 mg/day prednisolone or equivalent is allowed, provided that the
steroid dose has been stable or tapering for at least 14 days prior to the first
dose of CA-4948
2. Inhaled, intranasal, intraarticular and topical steroids are permitted
6. Use of any investigational agent within 28 days or 5 half-lives, whichever is shorter,
prior to start of CA-4948
7. Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy,
with the exception of alopecia, that has not resolved to Grade ≤ 1 within 7 days prior
to start of CA-4948 unless approved by the Medical Monitor
8. Known allergy or hypersensitivity to any component of the formulation of CA-4948 used
in this study
9. Diagnosis of acute promyelocytic leukemia (APL, M3) for AML
10. Hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of CA-4948
for AML
11. Blast transformation of CML into AML
We found this trial at
10
sites
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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