Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Bevacizumab

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

bevacizumab

placebo

erlotinib HCl

Donald Strickland, M.D.

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)

A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.

Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade \>=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.

Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade \>=3. Data presented until cut-off date 28 January 2009.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.

Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).

Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.

Overall survival was defined as the length of time from randomization to death.

Genentech, Inc.

Safety-evaluable randomized participants who had received at least one complete or partial dose of bevacizumab or erlotinib/placebo.

Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.

Bevacizumab + Placebo

Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.

Bevacizumab + Erlotinib

Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily

Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily

Total

Age, Continuous

Sex: Female, Male

Roche Trial Information Hotline

Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.

Progression-free Survival (PFS)

Pulmonary hemorrhage

GI perforation

ATE events

Proteinuria

Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration-time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m\^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.

Carboplatin + Paclitaxel

Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m\^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.

Carboplatin + Gemcitabine

Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m\^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.

Carboplatin + Docetaxel

Participants received IV dose of Cisplatin 80 mg/m\^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m\^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.

Cisplatin + Gemcitabine

Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.

Other

Safety-evaluable enrolled participants: All participants who enrolled and received at least one dose of chemotherapy or Bevacizumab. N= Number of participants analyzed.

Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase

Hypertension

Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed.

Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase

Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. At the time of the 28 January 2009 data cutoff, an additional 25 patients had been randomized.

Number of Participants With Any Adverse Events During Post-Chemotherapy Phase

Adverse Event

Concomitant/ancillary therapy

Patient's Decision to Discontinue

Investigator's Decision

Unwillingness or inability to comply with study

Unrelated intercurrent illness

Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m\^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.

Enrolled participants: All participants who were enrolled in the study. N= Number of participants analyzed.

Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase

Bevacizumab: AE

Bevacizumab: Concomitant/ancillary therapy

Bevacizumab: Patient's Decision to Discontinue

Bevacizumab: Investigator's Decision

Bevacizumab: Unwillingness or inability to comply

Bevacizumab: Unrelated intercurrent illness

Bevacizumab: Sponsor's decision

Bevacizumab: Lost to follow-up

Erlotinib/placebo: AE

Erlotinib/placebo: Concomitant/ancillary therapy

Erlotinib/placebo:Patient's Decision

Erlotinib/placebo: Investigator's Decision

Erlotinib/placebo:Unwillingness/inability comply

Erlotinib/placebo: Unrelated intercurrent illness

Erlotinib/placebo: Sponsor's decision

Erlotinib/placebo: Lost to follow-up

Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib.

orally daily.

Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.. N= Number of participants analyzed.

Incidence of Study Treatment Discontinuation

Intent-to-treat population included all participants who were randomized during the post-chemotherapy phase.

Overall Survival

Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.

Bevacizumab + Chemotherapy

Chemotherapy Phase

Post Chemotherapy Phase

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Urinary Bladder Neoplasms

Congenital Abnormalities

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Urethral Cancer

Poly(ADP-ribose) Polymerase Inhibitors

Rucaparib

The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.

Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.

Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).

Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.

Foundation Medicine

pharmaand GmbH

Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.

HRD Unknown

Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.

HRD Negative

Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.

HRD Positive

Overall

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The study was terminated early based on an interim analysis by the Data Monitoring Committee that demonstrated that ORR did not meet the protocol-defined continuance criteria. There were no confirmed responses observed.

Medical Information Department

Intent-to-treat Population (ITT) with measurable disease at Baseline - The ITT population includes all patients who received at least 1 dose of rucaparib. One patient each in the HRD negative and HRD positive groups did not have measurable disease at Baseline.

Objective Response Rate (ORR) Per RECIST Version 1.1

Intent-to-Treat population - all patients who received at least 1 dose of rucaparib

Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator

Cycle 2 Day 1

Cycle 3 Day 1

Cycle 4 Day 1

Safety population - all patients who received at least 1 dose of rucaparib and who had at least 1 PK sample collected. The number analyzed at each timepoint includes only those participants who remained on study and with viable samples collected at that timepoint.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)	NCT00257608	Non-Small Cell ...	bevacizumab placebo erlotinib HCl	18 Years -	Genentech, Inc.
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma	NCT03397394	Bladder Cancer Urothelial Carc... Metastatic Urot... Renal Pelvis Ca... Ureter Carcinom... Urinary Bladder... Urethra Carcino... Muscle Invasive...	Rucaparib	18 Years -	pharmaand GmbH
TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy	NCT04596033	Melanoma Non-small Cell ... Squamous Cell C... Urothelial Carc... Renal Cell Carc... Small-cell Lung... Cutaneous Squam... Anal Squamous C... Merkel Cell Car...	GEN-011 IL-2 Fludarabine Cyclophosphamid...	18 Years -	Genocea Biosciences, Inc.

Spots Global Cancer Trial Database for atlas

Every month we try and update this database with for atlas cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for atlas

Every month we try and update this database with for atlas cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for atlas cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.