Stage IV Small Cell Lung CancerPhase 1/2PINNACLENCT01859741

A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy

A Phase 1/2 study testing OMP-59R5, Etoposide and Cisplatin or Carboplatin in people with Stage IV Small Cell Lung Cancer, run by OncoMed Pharmaceuticals, Inc. at 35 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 (tarextumab) in combination with etoposide (EP) for 6 cycles followed a Phase 2, multi center, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stage IV Small Cell Lung Cancer
What is being tested?: OMP-59R5, Etoposide and Cisplatin or Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 172 participants
Where: 35 sitesUnited States
Study dates: 7 Jan 2012to 8 May 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must meet all of the following criteria to be eligible for the study:
Histologically or cytologically documented extensive stage small cell lung cancer.
Adults of 18 years of age or older.
Performance Status (ECOG) of 0 or 1.
Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
Adequate organ function:

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Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL).
Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault formula).
Adequate hepatic function (alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], ALT may be ≤ 5 x ULN if due to liver metastases but cannot be associated with concurrent elevated bilirubin >1.5 times the upper limit of normal (ULN) unless it is approved by the Sponsor's Medical Monitor).
Prothrombin Time (PT)/International Normalized Ration (INR) ≤1.5 × ULN, activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
Written consent on an Institutional Review Board (IRB)/IndependentEthics Committee (IEC)-approved Informed Consent Form prior to any study-specific evaluation.
For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.
Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.

Who cannot join

Subjects who meet any of the following criteria will not be eligible for participation in the study:
Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.
Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer.
Presence of any serious or uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirement.
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within 6 months prior to the first administration of study drug.
A history of malignancy with the exception of:

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Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
Adequately treated stage I cancer from which the subject is currently in remission, or
Any other cancer from which the subject has been disease-free for ≥ 3 years
Known human immunodeficiency virus (HIV) infection.
Females who are pregnant or breastfeeding.
Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg daily for port catheter is allowed)

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

University of Michigan Medical Center, Clinical Trials Office
Ann Arbor, Michigan, 48109
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Georgia Cancer Specialists, PC
Atlanta, Georgia, 30341
Texas Oncology-South Austin
Austin, Texas, 78745
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Weinberg Cancer Institute
Baltimore, Maryland, 21237
Texas Oncology-Bedford
Bedford, Texas, 76022
Oncology and Hematology Associates of Southwest Virginia Inc.
Blacksburg, Virginia, 24060
Roswell Park Cancer Institute
Buffalo, New York, 14263
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404
Univeristy of Chicago Medical Center
Chicago, Illinois, 60637
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Case Western Reserve University
Cleveland, Ohio, 44106
Texas Oncology, P.A.
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Sarah Cannon
Fort Myers, Florida, 33905
Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research
Greenville, South Carolina, 29605
The University of Texas MD A nderson Cancer Center
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Norton Cancer Institute
Louisville, Kentucky, 40202
Minnesota Oncology Hematology , P.A.
Minneapolis, Minnesota, 55404
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06520
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Ocala Oncology Center, PL
Ocala, Florida, 34474
Oncology Hematology West PC, dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, 15232
Providence Cancer Center Oncology and Hematology Care Eastside
Portland, Oregon, 97213
Highlands Oncology Group
Rogers, Arkansas, 72758
Cancer Care Network of South Texas
San Antonio, Texas, 78217
Swedish Cancer Institute
Seattle, Washington, 98104
Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)

Read the detailed description

The Phase 1b lead-in portion of the study was conducted to determine the MTD of OMP-59R5 administered along with EP. The Phase 2 portion of the study was multi-center, randomized, and placebo-controlled. Subjects who qualified for enrollment into the Phase 2 portion of the study were randomized in a 1:1 ratio to receive study treatment of tarextumab along with EP (Arm A) or placebo along with EP (Arm B).

Conditions: Stage IV Small Cell Lung Cancer
Being tested: OMP-59R5, Etoposide, Placebo, Cisplatin or Carboplatin
Keywords: Newly diagnosed Stage IV Small Cell Lung Cancer
Medical subject headings: Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OMP-59R5Drug
Also called Tarextumab
OMP-59R5 administered intravenously
EtoposideDrug
administered intravenously
PlaceboDrug
administered IV
Cisplatin or CarboplatinDrug
administered intravenously

Study groups in NCT01859741
Study group	Role	What they receive
OMP-59R5 Combination with Etoposide and Cisplatin	Experimental	Not described Receives: Drug: OMP-59R5; Drug: Etoposide; Drug: Placebo; Drug: Cisplatin or Carboplatin
Etoposide and Cisplatin plus Placebo	Experimental	Not described Receives: Drug: OMP-59R5; Drug: Etoposide; Drug: Placebo; Drug: Cisplatin or Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs)
To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Day 21 cycle of 1 OMP-59R5 administration or had discontinued due to drug-related toxicity.
Measured: Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 1b: Overall Response (Response Evaluable Population)
The best overall response is defined as the best Investigator-assessed response recorded from the start of the treatment until disease progression in the following order of importance: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE). Response evaluable population includes subjects who received 1 partial dose of OMP-59R5 and at at least 1 post tumor assessment.
Measured: Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 2: Progression Free Survival (ITT Population)
To determine the improvement in Progression Free Survival (PFS) resulting from the addition of tarextumab to etoposide and platinum therapy (EP) in subjects receiving first-line therapy for extensive stage small cell lung cancer. PFS is based on the Investigator-assessments of tumor response which is defined as the number of days from randomization until death or disease progression as defined by RECIST criteria for the ITT Population.
Measured: Up to 1 year until disease progression or death.
Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population)
The response rate is the number of subjects per treatment arm who have either a complete response (CR) or partial response (PR) for best overall response (according to RECIST criteria) divided by the number of subjects randomized to the respective arms.
Measured: Up to 1 year in absence of unacceptable toxicity or disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 20128 May 2017

First posted22 May 2013 (estimated)
Study start7 Jan 2012
Primary completion18 Apr 2017
Study completion8 May 2017

Why it stopped: OMP-59R5 did not improve PFS.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stage IV Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01859741
Sponsor's protocol ID: 59R5-003
Acronym: PINNACLE
Status last verified: Sep 2020
First submitted: 16 May 2013
Last updated: 9 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stage IV Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)
ClinicalTrials.gov ID: NCT01859741
Acronym / sponsor ID: PINNACLE / 59R5-003
Conditions: Stage IV Small Cell Lung Cancer
Keywords: Newly diagnosed Stage IV Small Cell Lung Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: OMP-59R5 did not improve PFS.
Enrolment: 172 participants (actual)
Lead sponsor: OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 7 Jan 2012 (actual)
Primary completion: 18 Apr 2017 (actual)
Study completion: 8 May 2017 (actual)
First posted: 22 May 2013 (estimated)
Results: Posted 1 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
OMP-59R5 Combination with Etoposide and Cisplatin	Experimental	Drug: OMP-59R5, Drug: Etoposide, Drug: Placebo, Drug: Cisplatin or Carboplatin
Etoposide and Cisplatin plus Placebo	Experimental	Drug: OMP-59R5, Drug: Etoposide, Drug: Placebo, Drug: Cisplatin or Carboplatin

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Histologically or cytologically documented extensive stage small cell lung cancer.
Adults of 18 years of age or older.
Performance Status (ECOG) of 0 or 1.
Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
Adequate organ function:

Key exclusion criteria (12 listed)

Subjects who meet any of the following criteria will not be eligible for participation in the study:
Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.
Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer.
Presence of any serious or uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirement.
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within 6 months prior to the first administration of study drug.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OMP-59R5Also: TarextumabOMP-59R5 administered intravenously	Drug	Etoposide and Cisplatin plus Placebo, OMP-59R5 Combination with Etoposide and Cisplatin
Etoposideadministered intravenously	Drug	Etoposide and Cisplatin plus Placebo, OMP-59R5 Combination with Etoposide and Cisplatin
Placeboadministered IV	Drug	Etoposide and Cisplatin plus Placebo, OMP-59R5 Combination with Etoposide and Cisplatin
Cisplatin or Carboplatinadministered intravenously	Drug	Etoposide and Cisplatin plus Placebo, OMP-59R5 Combination with Etoposide and Cisplatin

Primary outcome

Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs)
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.
To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Day 21 cycle of 1 OMP-59R5 administration or had discontinued due to drug-related toxicity.
Phase 1b: Overall Response (Response Evaluable Population)
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.
The best overall response is defined as the best Investigator-assessed response recorded from the start of the treatment until disease progression in the following order of importance: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE). Response evaluable population includes subjects who received 1 partial dose of OMP-59R5 and at at least 1 post tumor assessment.
Phase 2: Progression Free Survival (ITT Population)
Time frame: Up to 1 year until disease progression or death.
To determine the improvement in Progression Free Survival (PFS) resulting from the addition of tarextumab to etoposide and platinum therapy (EP) in subjects receiving first-line therapy for extensive stage small cell lung cancer. PFS is based on the Investigator-assessments of tumor response which is defined as the number of days from randomization until death or disease progression as defined by RECIST criteria for the ITT Population.
Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population)
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression
The response rate is the number of subjects per treatment arm who have either a complete response (CR) or partial response (PR) for best overall response (according to RECIST criteria) divided by the number of subjects randomized to the respective arms.

Results and safety

Results posted to the registry on 1 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P1B: OMP-59R5 5mg/kg + ETO + CIS	3	0
P1B: OMP-59R5 7.5 mg/kg + ETO + CIS	3	0
P1B: OMP-59R5 10 mg/kg + ETO + CIS	6	0
P1B: OMP-59R5 12.5 mg/kg + ETO + CIS	3	0
P1B: OMP-59R5 15 mg/kg + ETO + CIS	6	0
P1B: OMP-59R5 15mg/kg + ETO + CARB	6	0
P2: Placebo + CIS or CARB	72	2
P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB	73	3

Primary outcome: Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs)

Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.. Count of participants. Unit: Participants

Measure	P1B: OMP-59R5 5mg/kg + ETO + CIS n = 3	P1B: OMP-59R5 7.5 mg/kg + ETO + CIS n = 3	P1B: OMP-59R5 10 mg/kg + ETO + CIS n = 5	P1B: OMP-59R5 12.5 mg/kg + ETO + CIS n = 3	P1B: OMP-59R5 15 mg/kg + ETO + CIS n = 6	P1B: OMP-59R5 15mg/kg + ETO + CARB n = 6
Value	0	0	1	0	0	0

Population analysed: The MTD of OMP-59R5 in combination with etoposide and cisplatin or carboplatin was not reached and the recommended phase 2 dose was determined to be 15 mg/kg every 21-day cycle.

Primary outcome: Phase 1b: Overall Response (Response Evaluable Population)

Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.. Count of participants. Unit: Participants

Measure	P1B: OMP-59R5 5mg/kg + ETO + CIS n = 3	P1B: OMP-59R5 7.5 mg/kg + ETO + CIS n = 3	P1B: OMP-59R5 10 mg/kg + ETO + CIS n = 5	P1B: OMP-59R5 12.5 mg/kg + ETO + CIS n = 3	P1B: OMP-59R5 15 mg/kg + ETO + CIS n = 6	P1B: OMP-59R5 15mg/kg + ETO + CARB n = 6
Complete Response	0	0	0	0	0	0
Partial Response	3	2	4	2	5	4
Stable Disease	0	1	1	1	0	1
Progressive Disease	0	0	0	0	1	1
Not Evaluated	0	0	0	0	0	0
Missing	0	0	0	0	0	0

Primary outcome: Phase 2: Progression Free Survival (ITT Population)

Time frame: Up to 1 year until disease progression or death.. Count of participants. Unit: Participants

Measure	P2: Placebo + CIS or CARB n = 72	P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB n = 73
Disease Progression or Death	56	51
Did not Progress or Die	16	22

Primary outcome: Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population)

Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression. Count of participants. Unit: Participants

Measure	P2: Placebo + CIS or CARB n = 72	P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB n = 73
Complete Response	2	1
Partial Response	49	49
Stable Disease	10	9
Progressive Disease	4	2
Not Evaluable	1	1
No Post-Baseline Tumor Assessment Collected	6	11

Adverse events

Time frame: Adverse event and serious adverse event data are collected from the time of first administration of OMP-59R5, etoposide or platinum therapy up to 4 weeks after the last administration OMP-59R5, etoposide or platinum therapy, whichever is discontinued last but but before the initiation of a new anti-cancer therapy. All cause mortality was collected every 3 months until death, loss to follow-up or study termination by the sponsor (up to 35 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P1B: OMP-59R5 5mg/kg + ETO + CIS	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
P1B: OMP-59R5 7.5 mg/kg + ETO + CIS	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
P1B: OMP-59R5 10 mg/kg + ETO + CIS	6 of 6 (100%)	6 of 6 (100%)	4 of 6
P1B: OMP-59R5 12.5 mg/kg + ETO + CIS	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
P1B: OMP-59R5 15 mg/kg + ETO + CIS	0 of 6 (0%)	6 of 6 (100%)	5 of 6
P1B: OMP-59R5 15mg/kg + ETO + CARB	3 of 6 (50%)	6 of 6 (100%)	4 of 6
P2: Placebo + CIS or CARB	29 of 68 (42.6%)	68 of 68 (100%)	51 of 72
P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB	37 of 69 (53.6%)	69 of 69 (100%)	51 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OMP-59R5, Etoposide and Cisplatin or Carboplatin in people with Stage IV Small Cell Lung Cancer, run by OncoMed Pharmaceuticals, Inc. at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) (time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01859741.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.