Ovarian CancerPhase 1/2ZACFASTNCT00862836

Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)

A Phase 1/2 study testing Vandetanib in people with Ovarian Cancer, run by Genzyme, a Sanofi Company at 5 sites in Germany.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: Vandetanib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 5 sitesGermany
Study dates: Apr 2009to Sep 2010
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease.
Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.
Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).
Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.

Who cannot join

Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function
Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse
More than two prior lines of chemotherapy.
Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.
Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

Research Site
Berlin
Research Site
Essen, North Rhine-Westphalia
Research Site
Kiel, Schleswig-Holstein
Research Site
Ulm, Baden-Wurttemberg
Research Site
Wiesbaden, Hesse

Other trials in Germany

About this study

Official title: Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study

This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.

Conditions: Ovarian Cancer
Being tested: Vandetanib
Keywords: ZD6474, Vandetanib, Zactima, Ovarian Cancer, Phase I, Phase II, Randomized, Safety
Medical subject headings: Ovarian Neoplasms

What participants receive

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

VandetanibDrug
Also called Zactima
100mg doses orally, once daily

Study groups in NCT00862836
Study group	Role	What they receive
1	Experimental	Vandetanib added to standard therapy (pegliposomal doxorubicin) Receives: Drug: Vandetanib

What is being measured

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

Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).
Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)
Measured: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.
Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Measured: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.
Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)
Measured: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.
Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).
Measured: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.
Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)
Measured: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.
Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Measured: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.

Secondary outcomes (2)

Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).
Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.
Measured: From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.
Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).
Median overall survival (OS)
Measured: From date of registration (Informed Consent Form completed) until the date of death.

Timeline

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

Apr 2009Sep 2010

First posted17 Mar 2009 (estimated)
Study startApr 2009
Primary completionSep 2010
Study completionSep 2010

Why it stopped: Lack of efficacy

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 (1)Papers the sponsor has linked to this study.
Other trials for Ovarian 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00862836
Sponsor's protocol ID: D4200C00083
Other IDs: 2008-005557-38, 2008
Acronym: ZACFAST
Status last verified: Aug 2016
First submitted: 16 Mar 2009
Last updated: 10 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Harter P, Sehouli J, Kimmig R, Rau J, Hilpert F, Kurzeder C, Elser G, du Bois A. Addition of vandetanib to pegylated liposomal doxorubicin (PLD) in patients with recurrent ovarian cancer. A randomized phase I/II study of the AGO Study Group (AGO-OVAR 2.13). Invest New Drugs. 2013 Dec;31(6):1499-504. doi: 10.1007/s10637-013-0011-3. Epub 2013 Sep 5.
PubMed 24005613

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 Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study
ClinicalTrials.gov ID: NCT00862836
Acronym / sponsor ID: ZACFAST / D4200C00083
Conditions: Ovarian Cancer
Keywords: ZD6474, Vandetanib, Zactima, Ovarian Cancer, Phase I, Phase II, Randomized, Safety
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of efficacy
Enrolment: 15 participants (actual)
Lead sponsor: Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 17 Mar 2009 (estimated)
Results: Posted 11 Oct 2012

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: VandetanibVandetanib added to standard therapy (pegliposomal doxorubicin)

Who may qualify

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

Key inclusion criteria (4 listed)

Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease.
Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.
Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).
Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.

Key exclusion criteria (6 listed)

Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function
Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse
More than two prior lines of chemotherapy.
Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.

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
VandetanibAlso: Zactima100mg doses orally, once daily	Drug	1

Primary outcome

Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).
Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.
Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.
Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.
Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.
Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)
Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.
Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).

2 secondary outcomes

Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).
Time frame: From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.
Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).
Time frame: From date of registration (Informed Consent Form completed) until the date of death.

Results and safety

Results posted to the registry on 11 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vandetanib 100 mg	15	14

Primary outcome: Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).

Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.. Number. Unit: Participants

Measure	Vandetanib 100 mg n = 14
Value	9

Primary outcome: Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.

Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.. Number. Unit: Participants

Measure	Vandetanib 100 mg n = 14
Value	3

Primary outcome: Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.

Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.. Number. Unit: Participants

Measure	Vandetanib 100 mg n = 14
Value	5

Primary outcome: Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.

Time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.. Number. Unit: Participants

Measure	Vandetanib 100 mg n = 14
Value	5

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vandetanib 100 mg	3 of 14 (21.4%)	14 of 14 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24005613Harter P, Sehouli J, Kimmig R, Rau J, Hilpert F, Kurzeder C, Elser G, du Bois A. Addition of vandetanib to pegylated liposomal doxorubicin (PLD) in patients with recurrent ovarian cancer. A randomized phase I/II study of the AGO Study Group (AGO-OVAR 2.13). Invest New Drugs. 2013 Dec;31(6):1499-504. doi: 10.1007/s10637-013-0011-3. Epub 2013 Sep 5.

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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.

Clinical Sciences & Operations study director

Sanofi

5 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 Vandetanib in people with Ovarian Cancer, run by Genzyme, a Sanofi Company at 5 sites in Germany.

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 4 inclusion and 6 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 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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 11 Oct 2012). 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?

Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). (time frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.). The study lists 6 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 NCT00862836, which also lists 1 linked publication.

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 10 Oct 2016.