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PIKASSO-01 : A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAcute Lymphoblastic Lymphoma,Adrenocortical carcinoma,Anus,Astrocytoma,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cancer of Unknown Primary,Central Nervous System,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Langerhans Cell Histiocytosis,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,T-Cell Lymphoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

This phase I study is evaluating how safe and effective targeted therapy (LOXO-783) is alone, or when given with other anti-cancer therapies (such as fulvestrant, imlunestrant, abemaciclib, paclitaxel, and aromatase inhibitors) in people with advanced breast cancer or other solid cancers with a PIK3CA H1047R mutation.
 

This trial is treating patients with advanced breast cancer or other solid cancers with PIK3CA H1047R mutations.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Commercial Sponsor

Eli Lilly and Company

Summary

This trial has two phases. In phase 1A, eligible participants will receive LOXO-783 as monotherapy, administered orally, in escalating doses. The next phase, Phase 1B, has six arms. In Phase 1B Part A, participants will receive LOXO-783 (administered orally) in combination with fulvestrant (administered intramuscularly), imlunestrant (administered orally) or and aromatase inhibitor such as anastrozole, exemestane or letrozole (also administered orally). In Phase 1B Part B, participants will receive LOXO-783 (orally) in combination with abemaciclib (orally) and either physician's choice aromatase inhibitor (orally), fulvestrant (intramuscularly) or imlunestrant (orally). In Phase 1B Part C, participants will receive LOXO-783 (orally) in combination with fulvestrant (intramuscularly). In Phase 1B Part D, participants will receive LOXO-783 (orally) in combination with paclitaxel (intravenously). In Phase 1B Part E, participants will receive LOXO-783 (orally) as monotherapy. Phase 1B Part F, will involve multiple randomised dose levels of LOXO-783 (orally) with fulvestrant (intramuscularly).

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Heather Rootes
PCCTU.Breast@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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