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A Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT03451084
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Aslan Pharmaceuticals

Brief Summary:
ASLAN003-003 is a multi-center, Phase IIA study to evalute the efficacy of ASLAN003 in AML patients who are ineligible for standard treatment with an expansion cohort in relapsed/refractory patients, and to determine the appropriate dose of ASLAN003 in combination with azacitidine in older (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: ASLAN003 Phase 2

Detailed Description:

ASLAN003-003 is a multi-center, Phase IIA study to determine the optimum dose of ASLAN003 based on the safety, efficacy, and tolerability of varying doses of ASLAN003 (100 mg QD, 200 mg QD, 100 mg BID, and possibly 200 mg BID) administered to AML subjects daily for a continuous 28-day treatment cycle until disease relapse, disease progression, unacceptable toxicity, or withdrawal of consent.

The study has 2 parts and plans to enroll a total of 44 to 56 patients with 18 to 24 patients in Part 1 and 26 to 32 patients in Part 2 (comprising Parts 2A and 2B). The Overall Complete Remission Rate will be evaluated in AML patients not eligible for standard treatment (Part 1) and in relapsed and refractory AML patients (Part 2A) using the optimum dose of ASLAN003 established in Part 1 of the study. In Part 2B of the study, the appropriate dose of ASLAN003 in combination with azacitidine in older (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options will be determined.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Experimental: Part 1: Dose Level 1 Drug: ASLAN003
Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.

Experimental: Part 1: Dose Level 2 Drug: ASLAN003
Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.

Experimental: Part 1: Dose Level 3 Drug: ASLAN003
Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.

Experimental: Part 1: Dose Level 4 Drug: ASLAN003
Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.

Experimental: Part 2:ASLAN003 at Optinum Dose Level -1 & Azacitidine Drug: ASLAN003
Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.

Experimental: Part 2:ASLAN003 at Optinum Dose Level & Azacitidine Drug: ASLAN003
Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.




Primary Outcome Measures :
  1. Overall complete remission rate [ Time Frame: 4 months after LPI ]
    Defined as the proportion of patients with a best response of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), defined in accordance with the IWG Response Criteria in AML from day 29. Treatment failure is defined as not achieving any response 4 months after study treatment.


Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Through 28 days post last study medication administration ]
    Incidence of AEs, categorized in accordance to CTCAE 4.03 and changes from baseline in safety parameters (including vital signs, ECG parameters, clinical laboratory tests)

  2. Relapse Free Survival [ Time Frame: Through study completion, an average of 6 months. ]
    Defined as the time the criteria for remission (CR or CRi) are first met until there is evidence of patient relapse, regardless of whether the patient is still taking study drug.

  3. Clinical Benefit Rate [ Time Frame: 4 months after LPI ]
    Defined as the proportion of patients with an AML IWG best response of CR, CRi or PR.

  4. Tumor % change [ Time Frame: 29 days after LPI ]
    Tumor % change from baseline in BM blasts at Day 29.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are of or older than 18 years old in the United States or are of or older than the legal age in the respective countries at the time when written informed consent is obtained
  2. Patients who are able to understand and willing to sign the informed consent form (ICF)
  3. Patients who are diagnosed with AML according to the 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia (refer to Appendix 1: WHO Classification of Acute Myeloid Leukemia)
  4. Patients who have a sufficient archival or fresh BM aspiration sample for the evaluation of relevant exploratory endpoint.

Note: Patients who do not have sufficient archival BM aspiration sample and refuse to repeat the procedure may be enrolled in the trial only after written confirmation by ASLAN 5. Part 1: Patients who are ineligible for standard treatment of AML including to the following conditions:

  • Patients who are ineligible for chemotherapy, and have exhausted any approved and available treatment options. More details on patients who are considered as ineligible or unfit for chemotherapy as per Ferrara et al, Leukemia, 2013 can be found in Appendix 4.
  • Patients who have relapsed from prior remission;
  • Patients who have failed to respond to prior therapy including chemotherapy, hypomethylating agents, and bone marrow transplantation.

    5. Part 2A: Patients who have relapsed or refractory AML to treatments including chemotherapy, hypomethylating agents, bone marrow transplantation, and other anti-leukemic agents

    • Relapsed patients who have bone marrow blasts ≥5%; or reappearance of blasts in the blood; or development of extramedullary disease after prior CR or CRi
    • Refractory patients who have no CR or CRi after 2 courses of intensive induction treatment 5. Part 2B: Older patients (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.

      6. Patients who have an ECOG performance status of ≤ 2 7. Patients with adequate renal and hepatic function, as defined below:

  • Estimated Glomerular Filtration Rate (eGFR) or creatinine clearance (CrCl) (CrCl calculated by the Cockroft and Gault method) ≥ 40 ml/min/1.73 m2
  • Total bilirubin, AST, and ALT ≤ 1.5 × ULN

Exclusion Criteria:

  1. Patients who are diagnosed with de novo myeloid sarcoma without BM involvement
  2. Patients who are diagnosed with acute promyelocytic leukemia/retinoic acid receptor alpha (PML-RARA)
  3. Patients who received any other standard or investigational treatment for their leukemia within the last 7 days before starting the first dose of study drug, with the exception of leukapheresis and hydroxyurea
  4. Patients with unresolved serious toxicity (≥ CTCAE 4.03 Grade 2) from prior administration of standard or investigational treatment for their leukemia
  5. Patients who have a positive test for human immunodeficiency virus (HIV), viral hepatitis C infection (patients with sustained viral response are not excluded), active viral hepatitis B infection (positive hepatitis B surface antigen [HBsAg]) with hepatitis B virus deoxyribonucleic acid (DNA) exceeding 2000 IU/ml
  6. Patients who have a known history of liver cirrhosis Child-Pugh score B or C
  7. Patients who have any history of other malignancy unless in remission for more than 1 year (skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary)
  8. Female patients who are pregnant or breast-feeding
  9. Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment
  10. Patients with a history or presence of a clinically significant condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results
  11. Patients who have been previously treated with ASLAN003

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451084


Contacts
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Contact: Jamie Kwek +6562224235 aslan003-aml@aslanpharma.com
Contact: Jamie Kwek

Locations
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United States, Kentucky
1 Site Not yet recruiting
Louisville, Kentucky, United States, 40241
Australia, New South Wales
1 Site Recruiting
Albury, New South Wales, Australia
3 Sites Not yet recruiting
Darlinghurst, New South Wales, Australia
1 Site Not yet recruiting
Waratah, New South Wales, Australia
Australia, Queensland
1 Site Not yet recruiting
Douglas, Queensland, Australia
Australia, South Australia
1 Site Not yet recruiting
Adelaide, South Australia, Australia
Australia, Victoria
3 Sites Recruiting
Melbourne, Victoria, Australia
Singapore
3 Sites Recruiting
Singapore, Singapore
Sponsors and Collaborators
Aslan Pharmaceuticals

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Responsible Party: Aslan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03451084     History of Changes
Other Study ID Numbers: ASLAN003-003
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aslan Pharmaceuticals:
AML, ASLAN, DHODH

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors