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NCT02140606
An Open Phase I Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous Cafusertib Hydrochloride in Combination With Subcutaneous Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)
Phase 1 trial testing Cafusertib Hydrochloride in Leukemia, Myeloid, Acute. Status unknown.
1 December 2015
Quick facts
| Lead sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 May 2014 |
| Primary completion | 1 December 2015 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cafusertib Hydrochloride — full drug profile →
Conditions studied
- Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities
Time frame: 4 weeks
Sponsor's own description
To investigate safety, tolerability of cafusertib combination with low dose cytarabine (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for conventional or intensive treatment. The dose of cafusertib will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in AML patients. To determine the recommended dosage regimen for phase II.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02140606
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Leukemia, Myeloid, Acute
Currently open trials in the same condition.
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- NCT06643962 — Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearan · NA · recruiting
- NCT06382168 — DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting
Other Jiangsu Hansoh Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07468851 — A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radic · Phase 1, PHASE2 · not yet recruiting
- NCT07483437 — A Study of HS-20136-2 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07535970 — A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Part · Phase 1 · not yet recruiting
- NCT07503015 — Phase 1 Study of HS-20152 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07414953 — A Phase Ib Study of HS-10504 Combined Therapy in NSCLC · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02140606 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Last refreshed: 13 May 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02140606.
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