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Alectinib · 1 trial · 2 indications
This is a master screening entry with sub-study entries to capture the results of each arm. As such a primary outcome measure for this entry is not relevant, however this entry will be used to report the number of patients with a cancer containing the appropriate genetic alteration that have been successfully allocated and consented to each arm.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1: Alectinib | EXPERIMENTAL | This alectinib treatment arm is for adult, paediatric and TYA patients with ALK-positive cancers. |
| Treatment Arm 2: Atezolizumab | EXPERIMENTAL | This atezolizumab treatment arm is for adult, paediatric and TYA patients with cancers with high tumour mutational burden (TMB) or microsatellite instability high (MSI-high) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD). |
| Treatment Arm 3: Entrectinib | EXPERIMENTAL | This entrectinib treatment arm is for adult, paediatric and TYA patients with ROS1 gene fusion-positive cancers. |
| Treatment Arm 4: Trastuzumab in combination with pertuzumab | EXPERIMENTAL | This trastuzumab and pertuzumab treatment arm is for adult, paediatric and TYA patients with cancers with HER2 amplification or activating mutations. |
| Treatment Arm 5: Vemurafenib in combination with cobimetinib | EXPERIMENTAL | This vemurafenib and cobimetinib treatment arm is for BRAF V600 mutation-positive cancers occurring in adults only. |
| Treatment Arm 6: Capmatinib | EXPERIMENTAL | This capmatinib treatment arm is for adult patients with cancers harbouring MET dysregulations. |
| Name | Type | Description |
|---|---|---|
| Alectinib | DRUG | Adult patients will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Paediatric patients with a body weight ≥40 kg and who are able to swallow the capsules will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Each cycle of treatment will consist of 28 days and patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent. |
| Atezolizumab | DRUG | Adult patients will receive 1200 mg of atezolizumab intravenously every 21 days. Paediatric patients will receive atezolizumab at a dose of 15 mg/kg (maximum 1200 mg) every 21 days. Patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent. |
| Entrectinib | DRUG | Adult and paediatric patients with body surface area (BSA) ≥1.51 m\^2 will receive entrectinib orally at a dose of 600 mg daily dose (three 200 mg capsules per day). Paediatric patients with BSA \<1.51 m\^2 will receive a dose adjusted for BSA. Each cycle of treatment will consist of 28 days and patients may continue until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent. |
| Trastuzumab in combination with pertuzumab | DRUG | The initial loading dose of trastuzumab is 8 mg/kg body weight followed thereafter by a maintenance dose of 6 mg/kg body weight administered intravenously every 21 days. The initial loading dose of pertuzumab is 840 mg followed thereafter by a maintenance dose of 420 mg administered intravenously every 21 days. Paediatric patients will receive a dose of pertuzumab adjusted by body weight. Patients may continue until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent. |
| Vemurafenib in combination with cobimetinib | DRUG | Patients will receive vemurafenib at a dose of 960 mg (four tablets of 240 mg) orally on a twice daily schedule throughout a 28-day cycle. Patients will receive cobimetinib at a dose of 60 mg (three tablets of 20 mg) to be taken orally, once daily for 21 consecutive days (days 1 to 21 in each 28-day cycle); followed by a 7-day break. Patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent. |
| Capmatinib | DRUG | Patients will be administered capmatinib orally at a daily dose of 800 mg consisting of 400 mg (two 200 mg tablets) twice daily. Each cycle of treatment will consist of 28 days and patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent. |
THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA OUTLINED BELOW AND WITHIN THE SPECIFIC TREATMENT ARM APPENDIX TO WHICH THEY ARE ENROLLED. Core Inclusion Criteria: 1. Any patient (adult patients or children and TYA as defined in each treatment arm appendix) with histologically proven locally advan...
Alectinib is an investigational small molecule being studied for use in haematological malignancy, a type of cancer affecting the blood, bone marrow, and lymph nodes. It is currently in Phase 2 clinical development for this indication, and it is also being evaluated in solid tumours as part of the same trial platform.
Alectinib targets kinases, as it belongs to the -tinib class of kinase inhibitors. Kinases are enzymes that play a role in cell signaling and growth, and inhibiting them can help slow or stop the growth of cancer cells. This mechanism is being explored in the context of haematological malignancy and solid tumours.
Alectinib is being developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with haematological malignancy and solid tumours.
Alectinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to further assess its potential as a treatment for haematological malignancy and solid tumours.
Alectinib is being studied in the DETERMINE trial, registered as NCT05722886. This is a Phase 2, controlled, non-randomized, open-label master screening protocol conducted in the United Kingdom. The trial is recruiting 825 participants with haematological malignancy or solid tumours, and it uses biomarker selection to identify eligible patients.
Alectinib is the generic name for the drug, and it is sometimes referred to as alectinib hydrochloride, which is the salt form used in pharmaceutical formulations. In the context of clinical trials, the name Alectinib is used to identify the active substance being investigated for haematological malignancy and solid tumours.