Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Trastuzumab

Paclitaxel

Fulvestrant

Albumin-Bound Paclitaxel

Neratinib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Neratinib monotherapy in HER2 mutated cancers including cervical, salivary gland, and lung cancers containing EGFR exon 18 mutations.

Cohorts closed to enrollment in prior amendments: HER2 mutant cancers including bladder/urinary, colorectal, endometrial, breast HR-positive, TNBC HR-negative, lung, gastroesophageal, biliary, and ovarian; HER3 mutant solid tumor NOS; HER4 mutant solid tumor NOS; fibrolamellar carcinoma and EGFR brain.

Neratinib and Trastuzumab in HER2 mutated (TNBC, HR-negative) breast cancers.

Cohorts closed to enrollment in in prior amendments: colorectal, lung cancer HER2 mutant.

Neratinib, Fulvestrant and Trastuzumab or Fulvestrant and Trastuzumab or Fulvestrant alone in HER2 mutated (HR-positive with prior CDK4/6i) breast cancers.

Neratinib, Fulvestrant and Trastuzumab in HER2 mutated (HR-positive with or without CDK4/6i) breast cancers.

Neratinib and Paclitaxel in HER2 mutated bladder/urinary tract cancers.

Neratinib and Fulvestrant in HER2 mutated (HR-positive) breast cancers.

240 mg administered orally, once daily with food, continuously in 28 day cycles

500 mg administered as two 5 mL injections on Days 1, 15, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle

Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter

80mg/m\^2 administered IV on Days 1, 8, and 15 of every 4 week cycle

Chief Scientific Officer

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical, HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers.

The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).

Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (cervical cancer cohort).

Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Percentage of participants who achieve CR or PR per Response Evaluation Criteria in Sold Tumors Criteria (RECIST) v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts), per RECIST (if assessed) or PERCIST.

RECISTv1.1 for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

PERCISTv1.0: Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels

Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.

Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Part

Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).

Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Percentage of participants who achieve CR or PR per RECIST v1.1, or metabolic complete response via PERCIST v1.0.

For RECIST, A complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met. PERCIST criteria were used for patients without RECIST assessments.

Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.

Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.

Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.

The safety of neratinib in patients as measured by the incidence of treatment-emergent adverse events (TEAE), including serious adverse events (SAEs), in study participants. TEAEs are any adverse event that occurred on or after first dose of investigational product and up to 28 days after the last dose

Puma Biotechnology, Inc.

Neratinib Monotherapy (Neratinib 240 mg PO daily)

Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)

Neratinib + Fulvestrant

Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)

Neratinib + Paclitaxel

Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)

Neratinib + Trastuzumab

Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)

Neratinib + Fulvestrant + Trastuzumab

Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)

Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)

Fulvestrant + Trastuzumab

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race

Race/Ethnicity, Customized

Tumor type

Sr Director, Clinical Operations

Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)

Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)

Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy

Breast HR+ w. Prior CDK4/6i (Fulvestrant)

Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)

Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)

Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)

Cervical cancer patients treated with Neratinib Monotherapy

Cervical (Neratinib)

Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)

Breast cancer HR+ or HR- patients treated with Neratinib Monotherapy

Breast Cancer (Neratinib)

Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant)

Breast Cancer HR+ (Neratinib + Fulvestrant)

Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant + Trastuzumab)

Breast Cancer HR+ (Neratinib + Fulvestrant + Trastuzumab)

Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)

Breast Cancer HR- (Neratinib + Trastuzumab)

NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy

Lung Cancer HER2 Mutant (Neratinib)

NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)

Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)

NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy

Lung Cancer EGFR Mutant Exon 18 (Neratinib)

Biliary tract cancer patients treated with Neratinib Monotherapy

Biliary Tract Cancer (Neratinib)

Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy

Bladder/Urinary Tract Cancer (Neratinib)

Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)

Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)

Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy

Brain Cancer (Neratinib)

Colorectal cancer patients treated with Neratinib Monotherapy

Colorectal Cancer (Neratinib)

Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)

Colorectal Cancer (Neratinib + Trastuzumab)

Endometrial cancer patients treated with Neratinib Monotherapy

Endometrial Cancer (Neratinib)

Ovarian cancer patients treated with Neratinib Monotherapy

Ovarian Cancer (Neratinib)

Salivary gland cancer patients treated with Neratinib Monotherapy

Salivary Gland Cancer (Neratinib)

Gastroesophageal cancer patients treated with Neratinib Monotherapy

Gastroesophageal Cancer (Neratinib)

Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy

Fibrolamellar Carcinoma (FLC) (Neratinib)

HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy

HER2 NOS Cancer (Neratinib)

HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy

HER3 NOS Cancer (Neratinib)

HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy

HER4 NOS Cancer (Neratinib)

Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)

Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort)

Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)

Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Neratinib + Fulvestrant + Trastuzumab)

Breast Cancer HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)

Breast cancer HR+ patients having prior CDK4/6i treated with Fulvestrant Monotherapy

Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant)

Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Fulvestrant + Trastuzumab)

Spots Global Cancer Trial Database for solid tumors harboring somatic her2 or egfr exon 18 mutations