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Drugs & treatments › Paclitaxel

Paclitaxel: clinical trials recruiting now

88
Recruiting trials
15
Conditions studied
51
US states with sites
56
Countries

FDA drug label

FDA-approved
Yes. Paclitaxel appears in the FDA drug-label database. Marketed as Paclitaxel.
Drug class
Microtubule Inhibitor (FDA established pharmacologic class)
Boxed warning
The FDA label for Paclitaxel carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma ). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung c…

FDA recalls / enforcement

Reason (FDA)ClassificationStatusInitiated
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded pa — Hospira Inc. Class II (FDA: may cause temporary or reversible harm) Terminated 2012-06-27
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections. — Fresenius Kabi USA, LLC Class III (FDA: unlikely to cause harm) Terminated 2013-11-08

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Phase 1 15 Phase 2 53 Phase 3 27 Phase 4 1 Not applicable 2

Conditions being studied

ConditionTrials
Lung Cancer · Paclitaxel for Lung Cancer44
Breast Cancer · Paclitaxel for Breast Cancer39
Non Small Cell Lung Cancer · Paclitaxel for Non Small Cell Lung Cancer15
Triple Negative Breast Cancer · Paclitaxel for Triple Negative Breast Cancer9
Breast Neoplasms · Paclitaxel for Breast Neoplasms7
HER2-positive Breast Cancer · Paclitaxel for HER2-positive Breast Cancer6
Melanoma · Paclitaxel for Melanoma6
Pancreatic cancer · Paclitaxel for Pancreatic cancer6
Anatomic Stage II Breast Cancer AJCC v8 · Paclitaxel for Anatomic Stage II Breast Cancer AJCC v84
Carcinoma, Non-Small-Cell Lung · Paclitaxel for Carcinoma, Non-Small-Cell Lung4
Colorectal Cancer · Paclitaxel for Colorectal Cancer4
Anatomic Stage III Breast Cancer AJCC v8 · Paclitaxel for Anatomic Stage III Breast Cancer AJCC v83
HER2 Negative Breast Cancer · Paclitaxel for HER2 Negative Breast Cancer3
Stage IIIB Lung Cancer AJCC v8 · Paclitaxel for Stage IIIB Lung Cancer AJCC v83
Triple Negative Breast Neoplasms · Paclitaxel for Triple Negative Breast Neoplasms3

Recruiting trials involving Paclitaxel

Common questions

Is Paclitaxel FDA-approved?

Yes, marketed as Paclitaxel. Its FDA label carries a boxed warning.

How many recruiting trials involve Paclitaxel?

88 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.

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