Advanced Solid TumorsPhase 1NCT02318329

Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

A Phase 1 study testing FPA144 in people with Advanced Solid Tumors and Gastric Cancer, run by Five Prime Therapeutics, Inc. at 26 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors, Gastric Cancer, Transitional Cell Carcinoma of the Bladder
What is being tested?: FPA144
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 26 sitesin 3 countries
Study dates: Nov 2014to 30 Jun 2019
Phase: Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Life expectancy of at least 3 months
ECOG performance status of 0 to 1
In sexually-active patients, willingness to use 2 effective methods of contraception
Adequate hematological and organ function, confirmed by lab values
Tumor tissue must be available for prospective determination of FGFR2b overexpression
Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
Measurable disease as defined by RECIST version 1.1

Who cannot join

Untreated or symptomatic central nervous system (CNS) metastases
Impaired cardiac function or clinically significant cardiac disease
Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
Retinal disease or a history of retinal disease or detachment
Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea

Show all 15Show fewer

Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
History of prior malignancy except:
a) Curatively treated non-melanoma skin cancer or
b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway

Trial locations and contacts

26 sites in 3 countries.

Country

City, postcode or hospital

26 sites in 3 countries

United States13 sites

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The University of Chicago Medical Center
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030-4009
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medical Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
San Francisco, California, 74158
Innovative Cancer Research Institute
Whittier, California, 90603

Other trials in United States

South Korea9 sites

Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Seoul National University Hospital
Seoul, 110-744
Severance Hospital, Yonsei University
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Gangnam Severance Hospital
Seoul, 135-720
Korea University Anam Hospital
Seoul, 136-705
Seoul St. Mary's Hospital
Seoul, 137-701
SMG-SNU Boramae Medical Center
Seoul, 156-707

Other trials in South Korea

Taiwan4 sites

China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Read the detailed description

Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.

Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.

Conditions: Advanced Solid Tumors, Gastric Cancer, Transitional Cell Carcinoma of the Bladder
Being tested: FPA144
Keywords: FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer
Medical subject headings: Stomach Neoplasms, Urinary Bladder Neoplasms, Esophageal Neoplasms

What participants receive

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

FPA144Drug
Also called Bemarituzumab
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.

Study groups in NCT02318329
Study group	Role	What they receive
Part 1A: FPA144 Dose Escalation Solid Tumors	Experimental	Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg) Receives: Drug: FPA144
Part 1B: FPA144 Dose Escalation Gastric Cancer	Experimental	Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer Receives: Drug: FPA144
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors	Experimental	Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression Receives: Drug: FPA144

What is being measured

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

Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Measured: 4 weeks on average
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)
Measured: 16 weeks on average

Secondary outcomes (4)

Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.
- Summary of area under serum concentration-time curve, maximum serum concentration,
Measured: 16 weeks on average
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 16 weeks on average
Duration of Response Per RECIST 1.1 (Part 2 Only)
Duration of complete or partial response with 95% confidence intervals in gastric cancer population.
Measured: 16 weeks on average
Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.
- Summary of area under serum concentration-time curve, maximum serum concentration,
Measured: 16 weeks on average

Timeline

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

Nov 201430 Jun 2019

First posted17 Dec 2014 (estimated)
Study startNov 2014
Primary completion28 Feb 2019
Study completion30 Jun 2019

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorsStudies 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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02318329
Sponsor's protocol ID: FPA144-001
Status last verified: Dec 2021
First submitted: 25 Nov 2014
Last updated: 4 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Deidentified data will be provided to investigative sites requesting information for secondary publication.

Publications

Catenacci DV, Tesfaye A, Tejani M, Cheung E, Eisenberg P, Scott AJ, Eng C, Hnatyszyn J, Marina N, Powers J, Wainberg Z. Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design. Future Oncol. 2019 Jun;15(18):2073-2082. doi: 10.2217/fon-2019-0141. Epub 2019 May 16.
PubMed 31094225
Catenacci DVT, Rasco D, Lee J, Rha SY, Lee KW, Bang YJ, Bendell J, Enzinger P, Marina N, Xiang H, Deng W, Powers J, Wainberg ZA. Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma. J Clin Oncol. 2020 Jul 20;38(21):2418-2426. doi: 10.1200/JCO.19.01834. Epub 2020 Mar 13.
PubMed 32167861
Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.
PubMed 32965540

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 Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT02318329
Acronym / sponsor ID: FPA144-001
Conditions: Advanced Solid Tumors, Gastric Cancer, Transitional Cell Carcinoma of the Bladder
Keywords: FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Five Prime Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: 28 Feb 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 17 Dec 2014 (estimated)
Results: Posted 11 Mar 2020

Clinical summary

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

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part 1A: FPA144 Dose Escalation Solid Tumors	Experimental	Drug: FPA144Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)
Part 1B: FPA144 Dose Escalation Gastric Cancer	Experimental	Drug: FPA144Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors	Experimental	Drug: FPA144Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression

Who may qualify

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

Key inclusion criteria (8 listed)

Life expectancy of at least 3 months
ECOG performance status of 0 to 1
Adequate hematological and organ function, confirmed by lab values
Tumor tissue must be available for prospective determination of FGFR2b overexpression

Key exclusion criteria (15 listed)

Untreated or symptomatic central nervous system (CNS) metastases
Impaired cardiac function or clinically significant cardiac disease
Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
Retinal disease or a history of retinal disease or detachment
Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea

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
FPA144Also: BemarituzumabFPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.	Drug	Part 1A: FPA144 Dose Escalation Solid Tumors, Part 1B: FPA144 Dose Escalation Gastric Cancer, Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors

Primary outcome

Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
Time frame: 4 weeks on average
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)
Time frame: 16 weeks on average
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)

4 secondary outcomes

Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration
Time frame: 16 weeks on average
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: 16 weeks on average
Duration of Response Per RECIST 1.1 (Part 2 Only)
Time frame: 16 weeks on average
Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve
Time frame: 16 weeks on average

Results and safety

Results posted to the registry on 11 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg	3	0
Part 1A: FPA144 Dose Escalation Solid Tumors 1mg/kg	4	0
Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg	3	0
Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg	3	0
Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg	3	0
Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg	3	0
Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg	1	0
Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg	1	0
Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg	6	0
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors	52	0

Primary outcome: Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).

Time frame: 4 weeks on average. Count of participants. Unit: Participants

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n = 3	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg n = 4	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg n = 3	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg n = 3	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n = 3	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n = 3	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg n = 1	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n = 1	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n = 6
Value	0	0	0	0	0	0	0	0	0

Population analysed: All patients who received FPA144

Primary outcome: Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)

Time frame: 16 weeks on average. Count of participants. Unit: Participants

Measure	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg n = 1	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n = 1	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n = 6	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors n = 52
Value	1	1	6	48

Population analysed: All patients who received FPA144

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors	17 of 52 (32.7%)	48 of 52 (92.3%)	5 of 52

Limitations and caveats (from the sponsor): Inclusion of patients with refractory gastric cancer with short duration of drug exposure may have limited our ability to accurately evaluate the incidence of off-target effects adverse events in the study population, in particular corneal toxicity.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31094225Catenacci DV, Tesfaye A, Tejani M, Cheung E, Eisenberg P, Scott AJ, Eng C, Hnatyszyn J, Marina N, Powers J, Wainberg Z. Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design. Future Oncol. 2019 Jun;15(18):2073-2082. doi: 10.2217/fon-2019-0141. Epub 2019 May 16.
Background: PubMed 32167861Catenacci DVT, Rasco D, Lee J, Rha SY, Lee KW, Bang YJ, Bendell J, Enzinger P, Marina N, Xiang H, Deng W, Powers J, Wainberg ZA. Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma. J Clin Oncol. 2020 Jul 20;38(21):2418-2426. doi: 10.1200/JCO.19.01834. Epub 2020 Mar 13.
Background: PubMed 32965540Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.
Individual participant dataSharing planned: Yes. Deidentified data will be provided to investigative sites requesting information for secondary publication.

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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.

Medical Lead study director

Five Prime Therapeutics, Inc.

26 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FPA144 in people with Advanced Solid Tumors and Gastric Cancer, run by Five Prime Therapeutics, Inc. at 26 sites in 3 countries.

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 8 inclusion and 15 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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, South Korea, Taiwan. 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 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.

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 11 Mar 2020). 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?

Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). (time frame: 4 weeks on average). The study lists 2 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 NCT02318329, which also lists 3 linked publications.

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 4 Jun 2024.