Ovarian NeoplasmsPhase 1NCT01329549

Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)

A Phase 1 study testing BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min and BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min in people with Ovarian Neoplasms, run by Boehringer Ingelheim at 3 sites in Japan.

Terminated

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

Official record

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Trial summary

This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. Read more about this study

Who is it for?: Ages 20 years and older, women only
Conditions the study is for: Ovarian Neoplasms
What is being tested?: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min and BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 3 sitesJapan
Study dates: Apr 2011to Oct 2012
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 20 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients, age 20 years or older, with relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer
Up to 3 lines of prior chemo therapy, with treatment free interval of >6 months
Platinum based chemotherapy in the immediately preceding line.
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Who cannot join

Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or PLD.
More than 2 lines of prior therapies that contained angiogenesis inhibitor.
Patients for whom surgery is planned, e.g. interval debulking surgery.
History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.
Laboratory values indicating an increased risk for adverse events.
Significant cardiovascular diseases.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

1199.117.003 Boehringer Ingelheim Investigational Site
Akashi, Hyogo
1199.117.002 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo
1199.117.001 Boehringer Ingelheim Investigational Site
Hidaka, Saitama

Other trials in Japan

About this study

Official title: An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.

Conditions: Ovarian Neoplasms
Being tested: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Medical subject headings: Ovarian Neoplasms

What participants receive

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

BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*minDrug
BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*minDrug
BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*minDrug
BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

Study groups in NCT01329549
Study group	Role	What they receive
BIBF 1120 (low) + Carboplatin + PLD	Experimental	BIBF 1120 (low dose) + carboplatin (AUC5 mg/mLmin) + PLD (30 mg/m2) Receives: Drug: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mLmin
BIBF 1120 (medium) + Carboplatin + PLD	Experimental	BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mLmin) + PLD (30 mg/m2) Receives: Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mLmin
BIBF 1120 (high) + Carboplatin + PLD	Experimental	BIBF 1120 (high dose) + carboplatin (AUC5 mg/mLmin) + PLD (30 mg/m2) Receives: Drug: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mLmin

What is being measured

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

Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib
to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.
Measured: 28 days

Secondary outcomes (7)

Maximum Measured Plasma Concentration (Cmax)
Cmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). This endpoint has not been statistically analyzed in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Measured: 0.5h after the start of the infusion up to 56 days
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)
AUC0-tz was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Measured: 0.5h after the start of the infusion up to 56 days
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)
AUC0-∞ was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Measured: 0.5h after the start of the infusion up to 56 days
Time From Dosing to the Maximum Plasma Concentration (Tmax)
tmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Measured: 0.5h after the start of the infusion up to 56 days
Terminal Half-life (t1/2)
t1/2 was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Measured: 0.5h after the start of the infusion up to 56 days
Total Plasma Clearance (CL)
CL was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.
Detailed outcome measure time frame:
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
Measured: 0.5h after the start of the infusion up to 56 days
Apparent Volume of Distribution at Steady State (Vss)
Vss was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.
total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2
free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2
PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
Measured: 0.5h after the start of the infusion up to 56 days

Timeline

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

Apr 2011Oct 2012

First posted6 Apr 2011 (estimated)
Study startApr 2011
Primary completionOct 2012
Study completionOct 2012

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 Ovarian NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01329549
Sponsor's protocol ID: 1199.117
Status last verified: Nov 2014
First submitted: 1 Apr 2011
Last updated: 27 Nov 2014
Results posted: Yes, on ClinicalTrials.gov

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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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.
ClinicalTrials.gov ID: NCT01329549
Acronym / sponsor ID: 1199.117
Conditions: Ovarian Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 2 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 6 Apr 2011 (estimated)
Results: Posted 27 Nov 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
BIBF 1120 (low) + Carboplatin + PLD	Experimental	Drug: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mLminBIBF 1120 (low dose) + carboplatin (AUC5 mg/mLmin) + PLD (30 mg/m2)
BIBF 1120 (medium) + Carboplatin + PLD	Experimental	Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mLminBIBF 1120 (medium dose) + carboplatin (AUC5 mg/mLmin) + PLD (30 mg/m2)
BIBF 1120 (high) + Carboplatin + PLD	Experimental	Drug: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mLminBIBF 1120 (high dose) + carboplatin (AUC5 mg/mLmin) + PLD (30 mg/m2)

Who may qualify

Ages: 20 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Female patients, age 20 years or older, with relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer
Up to 3 lines of prior chemo therapy, with treatment free interval of >6 months
Platinum based chemotherapy in the immediately preceding line.
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Key exclusion criteria (7 listed)

Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or PLD.
More than 2 lines of prior therapies that contained angiogenesis inhibitor.
Patients for whom surgery is planned, e.g. interval debulking surgery.
History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.

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
BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*minBIBF 1120 twice daily along with standard therapy of PLD + CBDCA	Drug	BIBF 1120 (high) + Carboplatin + PLD
BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*minBIBF 1120 twice daily along with standard therapy of PLD + CBDCA	Drug	BIBF 1120 (medium) + Carboplatin + PLD
BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*minBIBF 1120 twice daily along with standard therapy of PLD + CBDCA	Drug	BIBF 1120 (low) + Carboplatin + PLD

Primary outcome

Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib
Time frame: 28 days
to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.

7 secondary outcomes

Maximum Measured Plasma Concentration (Cmax)
Time frame: 0.5h after the start of the infusion up to 56 days
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)
Time frame: 0.5h after the start of the infusion up to 56 days
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)
Time frame: 0.5h after the start of the infusion up to 56 days
Time From Dosing to the Maximum Plasma Concentration (Tmax)
Time frame: 0.5h after the start of the infusion up to 56 days
Terminal Half-life (t1/2)
Time frame: 0.5h after the start of the infusion up to 56 days
Total Plasma Clearance (CL)
Time frame: 0.5h after the start of the infusion up to 56 days
Apparent Volume of Distribution at Steady State (Vss)
Time frame: 0.5h after the start of the infusion up to 56 days

Results and safety

Results posted to the registry on 27 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib (150 mg) + Carboplatin + PLD	2	0

Primary outcome: Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib

Time frame: 28 days

Population analysed: Treated set

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nintedanib (150 mg) + Carboplatin + PLD	2 of 2 (100%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): The trial was prematurely terminated because of worldwide disruption of pegylated liposomal doxorubicin (PLD) supplies.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 7 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 27 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 27 Nov 2014). 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?

Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib (time frame: 28 days). 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 NCT01329549.

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 27 Nov 2014.