EligibleTrials

Carboplatin: clinical trials recruiting now

173
Recruiting trials
15
Conditions studied
51
US states with sites
58
Countries

FDA drug label

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

FDA-approved use

Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES ). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cis…

FDA recalls / enforcement

Reason (FDA)ClassificationStatusInitiated
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. — Hospira Inc. Class III (FDA: unlikely to cause harm) Terminated 2012-07-02
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. — Hospira Inc. Class I (FDA: reasonable probability of serious harm or death) Completed 2012-11-08
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig 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 par — Hospira Inc. Class II (FDA: may cause temporary or reversible harm) Terminated 2012-06-27
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. — Hospira Inc. Class I (FDA: reasonable probability of serious harm or death) Completed 2012-11-08

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Phase 1 39 Phase 2 113 Phase 3 46 Phase 4 2 Not applicable 5

Conditions being studied

ConditionTrials
Lung Cancer · Carboplatin for Lung Cancer114
Breast Cancer · Carboplatin for Breast Cancer48
Non Small Cell Lung Cancer · Carboplatin for Non Small Cell Lung Cancer36
Carcinoma, Non-Small Cell Lung · Carboplatin for Carcinoma, Non-Small Cell Lung13
Prostate Cancer · Carboplatin for Prostate Cancer12
Triple Negative Breast Cancer · Carboplatin for Triple Negative Breast Cancer10
Breast Neoplasms · Carboplatin for Breast Neoplasms7
Colorectal Cancer · Carboplatin for Colorectal Cancer7
Small Cell Lung Cancer · Carboplatin for Small Cell Lung Cancer7
Extensive Stage Small-cell Lung Cancer · Carboplatin for Extensive Stage Small-cell Lung Cancer5
Pancreatic cancer · Carboplatin for Pancreatic cancer5
Triple Negative Breast Neoplasms · Carboplatin for Triple Negative Breast Neoplasms4
Advanced Solid Tumor · Carboplatin for Advanced Solid Tumor3
Anatomic Stage II Breast Cancer AJCC v8 · Carboplatin for Anatomic Stage II Breast Cancer AJCC v83
Castration-Resistant Prostate Carcinoma · Carboplatin for Castration-Resistant Prostate Carcinoma3

Recruiting trials involving Carboplatin

Showing 100 of 173 recruiting trials.

Common questions

Is Carboplatin FDA-approved?

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

How many recruiting trials involve Carboplatin?

173 recruiting trials across 15 conditions.

Is this list of trials complete?

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

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