Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Malignant Mesothelioma

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Antineoplastic Agents

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Immunoglobulins

Tubulin Modulators

Anetumab ravtansine

Maytansine

Antimitotic Agents

Immunoconjugates

Immunologic Factors

Adult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study

BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies

BAY94-9343 (Anetumab ravtansine)

The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.

The primary objective of the study is to collect long-term safety information on anetumab ravtansine and to enable patients, who received an anetumab ravtansine-containing treatment in any Bayer-sponsored anetumab ravtansine parent study, to continue the treatment. The secondary objective is to further investigate the efficacy of the drug.

A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies

An Open-label, Multicenter Rollover Study to Provide Continued Treatment With Anetumab Ravtansine for Participants With Solid Tumors Who Were Enrolled in Previous Bayer-sponsored Studies

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.

Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%).

Bayer

Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.

Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.

8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.

Anetumab Ravtansine

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity

Due to the small sample size and heterogeneous population, survival distributions and the extent of long-term survival in the applicable populations cannot be reliably estimated from the study results.

Overall results were reported. Pooling was done because there is only a single patient treated with combination and no summary tables on a single patient.

Spots Global Cancer Trial Database for A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies

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Study Description

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