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nab-paclitaxel+ carboplatin

Phase 1

Small Cell Lung Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 20, 2020

Target and mechanism

Molecular targetTUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, TUBA1A
Target classInhibitor
ModalitySmall molecule

Also known as Nab-paclitaxel, Nab-Paclitaxel

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

nab-paclitaxel+ carboplatin · 1 trial · 10 indications

Phase 1 1
NCT02658214Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid TumorsSmall Cell Lung Carcinoma
COMPLETED32 Analytics
PHASE1COMPLETED
Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
Small Cell Lung CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Laboratory findings (including: clinical chemistry, hematology, and urinalysis)
Throughout the study, approximately three years

To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab

Incidence of Adverse Events
Throughout the study, approximately three years

To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab

Tumor assessment based on RECIST 1.1 (for cohort 6 only)
Throughout the study, approximately three years (for cohort 6 only)

To estimate the objective response rate (ORR) of durvalumab + tremelimumab + chemotherapy (for cohort 6 only)

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN)
Cohort 2EXPERIMENTALSmall-cell lung cancer (SCLC)
Cohort 3EXPERIMENTALTriple-negative breast cancer (TNBC)
Cohort 4EXPERIMENTALTriple-negative breast cancer (TNBC)
Cohort 5EXPERIMENTALGastric/gastro-esophageal junction (GEJ)
Cohort 6EXPERIMENTALPancreatic ductal adenocarcinoma (PDAC)
Cohort 7EXPERIMENTALEsophageal squamous cell carcinoma (ESCC)

Interventions

NameTypeDescription
paclitaxel + carboplatinDRUGIV infusion
carboplatin + etoposideDRUGIV infusion
gemcitabine + carboplatinDRUGIV infusion
nab-paclitaxel (paclitaxel-albumin) + carboplatinDRUGIV infusion
oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)DRUGIV infusion and bolus administration
durvalumabBIOLOGICALIV infusion
tremelimumabBIOLOGICALIV infusion
nab-paclitaxel (paclitaxel-albumin) + gemcitabineDRUGIV infusion
cisplatin + 5-fluorouracil (5FU)DRUGIV infusion
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. ≥18 years 2. Written informed consent 3. Patients with histologically or cytologically documented chemotherapy-naïve locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, gastric cancer/GEJ, PDAC and ESCC. 4. ECOG performance...

Countries:JapanSouth Korea
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Frequently asked questions about nab-paclitaxel+ carboplatin

What is Nab-Paclitaxel used for?

Nab-Paclitaxel is being studied for use in advanced or metastatic breast cancer and small cell lung carcinoma. It is an oncology small molecule being evaluated in combination with other agents as part of clinical trials for these indications.

Who is developing Nab-Paclitaxel?

Nab-Paclitaxel is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug in oncology indications.

What phase is Nab-Paclitaxel in?

Nab-Paclitaxel is in Phase 3 clinical development. It is an investigational drug being studied in active clinical trials for advanced or metastatic breast cancer and is not yet approved by regulatory authorities.

What clinical trials is Nab-Paclitaxel in?

Nab-Paclitaxel is part of the Phase 3 trial NCT04494425, which studies trastuzumab deruxtecan versus investigator's choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancer. This trial has enrolled 866 participants across multiple countries.

Is Nab-Paclitaxel the same as Nab-paclitaxel+carboplatin?

Nab-Paclitaxel is also known as Nab-paclitaxel+carboplatin, which refers to the combination regimen being studied. The drug is being evaluated in combination with carboplatin in clinical trials for certain cancers.