Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pictilisib · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm A: 340 mg pictilisib + CP | EXPERIMENTAL | Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). |
| Arm B: Placebo + CP | PLACEBO_COMPARATOR | Participants with advanced (Stage IV) or recurrent squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm A during the first 4 cycles with carboplatin + paclitaxel or after chemotherapy has been completed (Cycle \>/= 5). |
| Arm C: 340 mg pictilisib + CPB | EXPERIMENTAL | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B). |
| Arm D: Placebo + CPB | PLACEBO_COMPARATOR | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 340 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm C during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle \>/= 5). |
| Arm E: 260 mg pictilisib + CPB | EXPERIMENTAL | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P) plus bevacizumab (B). |
| Arm F: Placebo + CPB | PLACEBO_COMPARATOR | Participants with advanced (Stage IV) or recurrent non-squamous NSCLC will be administered placebo corresponding to 260 mg pictilisib plus carboplatin (C) plus paclitaxel (P). Participants with investigator assessed radiographic progression of NSCLC per RECIST 1.1 will be allowed to cross over to Arm E during the first 4 cycles with carboplatin + paclitaxel + bevacizumab or after chemotherapy has been completed (Cycle \>/= 5). |
| Part 1 (Cohort 1-2): Pictilisib 60 mg +Paclitaxel +Bevacizumab | EXPERIMENTAL | Pictilisib 60 mg will be administered orally (PO) once daily (QD) for 21 consecutive days of each 28-day cycle (21+7 schedule) with paclitaxel 90 milligrams per meter square (mg/m\^2) intravenously (IV) on Days 1, 8, and 15 and bevacizumab 10 milligrams per kilogram (mg/kg) IV on Days 1 and 15 of each 28-day cycle. In Cohort 1 (Part 1), pictilisib will be evaluated with paclitaxel only; participants in Cohort 1 (Part 1) will be eligible to receive bevacizumab starting at Cycle 2. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part 1 (Cohort 3): Pictilisib 100 mg+ Paclitaxel + Bevacizumab | EXPERIMENTAL | Pictilisib 100 mg will be administered PO QD for 21 consecutive days of each 28-day cycle (21+7 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 and bevacizumab 10 mg/kg IV on Days 1 and 15 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part 2 (Arm A: Cohort 1a): Pictilisib 165 mg + Paclitaxel | EXPERIMENTAL | Pictilisib 165 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity |
| Part 2 (Arm A: Cohort 2a): Pictilisib 250 mg + Paclitaxel | EXPERIMENTAL | Pictilisib 250 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part 2 (Arm A: Cohort 3a): Pictilisib 330 mg + Paclitaxel | EXPERIMENTAL | Pictilisib 330 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part2(Arm B:Cohort 1b):Pictilisib 200mg+Paclitaxel+Bevacizumab | EXPERIMENTAL | Pictilisib 200 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 and bevacizumab 10 mg/kg IV on Days 1 and 15 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part2(Arm B:Cohort 2b):Pictilisib 250mg+Paclitaxel+Bevacizumab | EXPERIMENTAL | Pictilisib 250 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 and bevacizumab 10 mg/kg IV on Days 1 and 15 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part2(Arm B:Cohort 3b):Pictilisib 260mg+Paclitaxel+Bevacizumab | EXPERIMENTAL | Pictilisib 260 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 and bevacizumab 10 mg/kg IV on Days 1 and 15 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part2(Arm C:Cohort 1c):Pictilisib 180mg+Paclitaxel+Trastuzumab | EXPERIMENTAL | Pictilisib 180 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 and trastuzumab 2-4 mg/kg IV on Days 1, 8, 15, and 22 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part2(Arm C:Cohort 2c):Pictilisib 260mg+Paclitaxel+Trastuzumab | EXPERIMENTAL | Pictilisib 260 mg will be administered PO QD for repeated rounds of 5 consecutive days followed by 2 consecutive drug-free days in each 28-day cycle (5+2 schedule) with paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 and trastuzumab 2-4 mg/kg IV on Days 1, 8, 15, and 22 of each 28-day cycle. Cycle 1 will be 29 days and subsequent cycles will be 28 days. Study treatment will continue until disease progression or unacceptable toxicity. |
| Part 3: Pictilisib 260 mg + Letrozole | EXPERIMENTAL | Pictilisib 260 mg will be administered PO QD continuously with letrozole 2.5 mg PO QD for each 28-day cycle. Study treatment will continue until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| pictilisib | DRUG | Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously. |
| Placebo | DRUG | Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously. |
| bevacizumab | DRUG | Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles. |
| carboplatin | DRUG | Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles. |
| paclitaxel | DRUG | Paclitaxel will be administered at 200 milligrams per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles. |
| Letrozole | DRUG | Letrozole will be administered PO at a dose of 2.5 mg QD for for each 28-day cycle. |
| Trastuzumab | DRUG | Trastuzumab will be administered IV at a dose of 2-4 mg/kg on on Days 1, 8, 15, and 22 of each 28-day cycle. |
Inclusion Criteria: * Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC) * Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor s...
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Pictilisib is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer and Breast Cancer. It is being developed by Roche Holding AG (RHHBY). The drug is currently in clinical development, with completed trials in these oncology indications.
Pictilisib is a PI3-kinase inhibitor, meaning it targets the PI3-kinase pathway. This pathway is involved in cell growth and survival, and its inhibition is being studied as a potential cancer treatment. The drug is being investigated in combination with other therapies for breast cancer and non-small cell lung cancer.
Pictilisib is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is a multinational healthcare company that operates in the pharmaceuticals and diagnostics sectors. The drug is an investigational small molecule in the oncology therapeutic area.
Pictilisib has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trial studied the drug in combination with other agents in breast cancer, while the Phase 2 trial evaluated it in non-small cell lung cancer. The drug is not approved and remains investigational.
Pictilisib has been studied in two completed clinical trials. NCT00960960 was a Phase 1 study in breast cancer, combining the drug with paclitaxel, with or without bevacizumab or trastuzumab, and with letrozole. NCT01493843 was a Phase 2 study in non-small cell lung cancer, testing the drug with carboplatin/paclitaxel and bevacizumab.
Yes, Pictilisib is also known as GDC-0941. The Phase 1 clinical trial NCT00960960 refers to the drug as PI3-Kinase Inhibitor GDC-0941. This alternative name is used in some clinical research contexts, and both names refer to the same investigational drug.