Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

recurrent non-small cell lung cancerstage III B non-small cell lung cancerstage IV non-small cell lung cancermalignant pleural effusionadenocarcinoma of the lungadenosquamous cell lung cancerbronchoalveolar cell lung cancerlarge cell lung cancersquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD)
Dose limiting toxicities per Protocol definition using (CTCAE), Version 3.0
12 months

Secondary Outcomes (1)

Area Under the Concentration-time Curve (AUC0 t) of Romidepsin in Combination With Erlotinib
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Days 1 and 8

Study Arms (4)

Cohort 1 (Erlotinib plus Romidepsin (8 mg/m^2))

EXPERIMENTAL

Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.

Combination Product: Erlotinib plus Romidepsin (8 mg/m^2)

Cohort 2 (Erlotinib plus Romidepsin (10 mg/m^2))

EXPERIMENTAL

Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.

Combination Product: Erlotinib plus Romidepsin (10 mg/m^2)

Cohort 3 (Erlotinib plus Romidepsin (10 mg/m^2)) + Antiemetic prophylaxis

EXPERIMENTAL

Interventions

Erlotinib plus Romidepsin (8 mg/m^2)Combination product

Also known as: Istodax®

Cohort 1 (Erlotinib plus Romidepsin (8 mg/m^2))

Erlotinib plus Romidepsin (10 mg/m^2)Combination product

Also known as: Istodax®

Cohort 2 (Erlotinib plus Romidepsin (10 mg/m^2))

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Erlotinib plus Romidepsin (8 mg/m^2)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
Erlotinib plus Romidepsin (10 mg/m^2)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
Erlotinib plus Romidepsin (10 mg/m^2) + Antiemetic prophylaxis
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Negative urine or serum pregnancy test on females of childbearing potential;
All women of childbearing potential must use an effective barrier method of contraception (an intrauterine contraceptive device \[IUCD\] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male patients should use a barrier method of contraception during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction (see Appendix D).

Sponsors & Collaborators

Celgene
Industrycollaborator
University of Texas Southwestern Medical Center
Otherlead
Genentech, Inc.

Study Sites (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

MeSH Terms

Conditions

Lung NeoplasmsNeoplasm MetastasisCarcinoma, Non-Small-Cell LungPleural Effusion, MalignantAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

Erlotinib Hydrochlorideromidepsin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Only phase 1 data are reported here as the maximum tolerated dose of romidepsin in combination with standard erlotinib 150 mg orally daily administration was 8 mg/m2. Therefore, it did not proceed to phase 2 (14 mg/m2 )

Results Point of Contact

Title: David Gerber, MD
Organization: UT Southwestern Medical Center

Study Officials

David E. Gerber, MD
Simmons Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

17 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Medicine

Study Record Dates

First Submitted

February 19, 2011

First Posted

February 24, 2011

Study Start

September 2009

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Cohort 1 (Erlotinib plus Romidepsin (8 mg/m^2))

Cohort 2 (Erlotinib plus Romidepsin (10 mg/m^2))

Cohort 3 (Erlotinib plus Romidepsin (10 mg/m^2)) + Antiemetic prophylaxis

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Cohort 4 (Erlotinib plus Romidepsin (8 mg/m^2)) + Antiemetic prophylaxis

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations