Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PKC412 · 1 trial · 2 indications
Best clinical response was defined as complete response (CR) or partial response (PR), according to NCI definitions for AML and the guidelines for defining responses in MDS.
Overall clinical response was defined as CR, PR, minor response (MR) or blast response (BR). CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.
Blood samples were collected for pharmacokinetic (PK) analysis.
Blood samples were collected for pharmacokinetic (PK) analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for pharmacokinetic (PK) analysis.
Blood samples were collected for pharmacokinetic (PK) analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for pharmacokinetic (PK) analysis.
Blood samples were collected for pharmacokinetic (PK) analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for PK analysis.
Blood samples were collected for analysis.
Blood samples were collected for analysis.
Blood samples were collected for analysis.
| Arm | Type | Description |
|---|---|---|
| PKC412 (Core) | EXPERIMENTAL | Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity. |
| FLT3 mutated PKC412 100 mg/day (E1) | EXPERIMENTAL | Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity. |
| FLT3 mutated PKC412 200 mg/day (E1) | EXPERIMENTAL | Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity. |
| FLT3 wild type PKC412 100 mg/day (E1) | EXPERIMENTAL | Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity. |
| FLT3 wild type PKC412 200 mg/day (E1) | EXPERIMENTAL | Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity. |
| FLT3 mutated PKC412 dose escalation | EXPERIMENTAL | Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity. |
| FLT3 mutated PKC+Itraconazole (E2) | EXPERIMENTAL | Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
| FLT3 wild type PKC412 dose escalation (E2) | EXPERIMENTAL | Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity. |
| FLT3 wild type PKC+Itraconazole (E2) | EXPERIMENTAL | Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| Itraconazole | DRUG | Itraconazole was commercially available. |
| PKC412 | DRUG | PKC412 was supplied as soft gelatin capsules containing 25 mg PKC412. |
Inclusion criteria: 1. Patients: with AML who are not candidates for myelosuppressive chemotherapy or with AML who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with MDS subtypes refractory anemia with excess blas...
PKC412 is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes. It is a targeted therapy that has been evaluated in a Phase 1 clinical trial in the United States. The drug is still in clinical development and is not yet approved.
PKC412 targets FLT3, a gene that encodes the FMS-like tyrosine kinase 3 receptor. This receptor is involved in cell growth and division, and mutations in FLT3 are common in Acute Myeloid Leukemia. By targeting FLT3, PKC412 aims to inhibit the signaling pathways that drive leukemia cell proliferation.
PKC412 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is responsible for the clinical development and manufacturing of this investigational drug for Acute Myeloid Leukemia and Myelodysplastic Syndromes.
PKC412 is in Phase 1 clinical development. It has completed one Phase 1 trial (NCT00045942) that enrolled 144 participants with Acute Myeloid Leukemia or Myelodysplastic Syndromes. The drug is investigational and has not received FDA approval.
PKC412 has been studied in one completed Phase 1 clinical trial, NCT00045942. This trial evaluated the drug in 144 participants with Acute Myeloid Leukemia or Myelodysplastic Syndromes, including those with wild-type or mutated FLT3. The trial was conducted in the United States and enrolled adults aged 18 years and older.