Lung CancerPhase 2NCT01588821

Cabozantinib in Advanced Solid Malignancies

A Phase 2 study testing Cabozantinib in people with Lung Cancer and Solid Tumor (Not Breast or Prostate Cancers), run by Massachusetts General Hospital at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Solid Tumor (Not Breast or Prostate Cancers)
What is being tested?: Cabozantinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Jun 2019
Phase: Phase 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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologic or cytologic diagnosis of a solid tumor (not breast or prostate) that is metastatic and refractory to or progressed following standard therapies
Has bony metastases
Agree to use medically accepted methods of contraception

Who cannot join

Pregnant or breastfeeding
Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents within 3 weeks of study entry(6 weeks for nitrosoureas/mitomycin C)
Received radiation to the thoracic cavity/GI tract (within 3 months of study entry), to bone or brain metastasis (within 14 days) or to any other site within 28 days
Received prior treatment with small molecule kinase inhibitor or hormonal therapy within 14 days/5 half-lives
Received therapy with another investigational agent within past 28 days
Has not recovered from toxicities due to prior therapies

Show all 10Show fewer

Primary brain tumor
Active brain metastases or epidural disease
Uncontrolled significant intercurrent or recent illness
Allergy or hypersensitivity to components of the study treatment formulation

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved the drug for this type of cancer, or for any use outside of research studies.

When cancer spreads from the primary tumor, one of the most commons sites it spreads to is bone. When cancer spreads to bone there can be significant symptoms such as pain.

Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been studied or is being studied in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney cancer.

Previous clinical research studies indicate that cabozantinib may also have activity against cancer once it has spread to the bones.

The purpose of this study is to find out if cabozantinib is effective in treating cancer that has spread to the bone.

Read the detailed description

Cabozantinib is a tablet that the subject will take by mouth. The subject will take it once per day. The study treatment with cabozantinib will be divided into 28 day cycles. A member of the study staff will give the subject a drug diary and explain to the subject how to use it to record doses of cabozantinib. This diary will also contain specific instructions about how the subject take cabozantinib.

Every 28 days the subject will undergo the following procedures: Physical examination, questions about any side effects the subject may have, blood samples for routine laboratory tests and research tests, urine sample, electrocardiogram (EKG), and questionnaires to measure quality of life and level of pain. Every two months the subject will undergo a CT scan or MRI to evaluate the subjects disease.

The investigators would like the subject to return to the study clinic for follow-up procedures about 4-5 weeks after the last dose of cabozantinib.

The subject can continue to receive the study drug for as long as their disease does not worsen and the subject do not experience unacceptable side effects.

Conditions: Lung Cancer, Solid Tumor (Not Breast or Prostate Cancers)
Being tested: Cabozantinib
Keywords: Metastatic, Refractory, Relapsed
Medical subject headings: Lung Neoplasms, Prostatic Neoplasms, Neoplasm Metastasis, Recurrence

What participants receive

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

CabozantinibDrug
Also called XL184
60 mg daily by mouth

Study groups in NCT01588821
Study group	Role	What they receive
Treatment Arm	Experimental	Cabozantinib Receives: Drug: Cabozantinib

What is being measured

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

Number of Participants With Bone Bio-marker Response
Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.
Measured: 8 Weeks

Secondary outcomes (6)

Number of Patients With Skeletal-related Events (SRE)
The number of patients that experience a SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)
Measured: 2 years
Quality of Life as Assessed by FACT-G
Quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G assesses patients' physical, social/family, emotional, and functional well-being. The total score can range from 0 to 108, with lower scores indicating higher quality of life. Patients without QOL scores at cycle 3 day 1 had their score from their last assessment carried forward.
Measured: From baseline to Cycle 3 Day 1 (approximately 2 months)
Overall Tumor Response Rate
The number of participants with a complete or partial response as measured by bone scan or PET-CT scan using. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Complete Response (CR): Disappearance of all target lesions
- Partial Response (PR): At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD
Measured: 2 years
MET Amplification in Tumor Sample
Response will be correlated with specific tumor genotype (MET amplification).
Measured: 2 years
Response to Cabozantinib in Bone Metastatic Disease
Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan
Measured: 2 years
Time to SRE
Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)
Measured: 2 years

Timeline

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

Jun 2012Jun 2019

First posted1 May 2012 (estimated)
Study startJun 2012
Primary completionJan 2017
Study completionJun 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.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588821
Sponsor's protocol ID: 12-091
Status last verified: Sep 2020
First submitted: 26 Apr 2012
Last updated: 29 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases
ClinicalTrials.gov ID: NCT01588821
Acronym / sponsor ID: 12-091
Conditions: Lung Cancer, Solid Tumor (Not Breast or Prostate Cancers)
Keywords: Metastatic, Refractory, Relapsed
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Jun 2012
Primary completion: Jan 2017 (actual)
Study completion: Jun 2019 (actual)
First posted: 1 May 2012 (estimated)
Results: Posted 10 Jan 2018

Clinical summary

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

When cancer spreads from the primary tumor, one of the most commons sites it spreads to is bone. When cancer spreads to bone there can be significant symptoms such as pain.

Previous clinical research studies indicate that cabozantinib may also have activity against cancer once it has spread to the bones.

The purpose of this study is to find out if cabozantinib is effective in treating cancer that has spread to the bone.

Detailed description

The investigators would like the subject to return to the study clinic for follow-up procedures about 4-5 weeks after the last dose of cabozantinib.

The subject can continue to receive the study drug for as long as their disease does not worsen and the subject do not experience unacceptable side effects.

Study design

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

Arm	Type	Receives
Treatment Arm	Experimental	Drug: CabozantinibCabozantinib

Who may qualify

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

Key inclusion criteria (3 listed)

Histologic or cytologic diagnosis of a solid tumor (not breast or prostate) that is metastatic and refractory to or progressed following standard therapies
Has bony metastases
Agree to use medically accepted methods of contraception

Key exclusion criteria (10 listed)

Pregnant or breastfeeding
Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents within 3 weeks of study entry(6 weeks for nitrosoureas/mitomycin C)
Received radiation to the thoracic cavity/GI tract (within 3 months of study entry), to bone or brain metastasis (within 14 days) or to any other site within 28 days
Received prior treatment with small molecule kinase inhibitor or hormonal therapy within 14 days/5 half-lives
Received therapy with another investigational agent within past 28 days

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
CabozantinibAlso: XL18460 mg daily by mouth	Drug	Treatment Arm

Primary outcome

Number of Participants With Bone Bio-marker Response
Time frame: 8 Weeks
Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.

6 secondary outcomes

Number of Patients With Skeletal-related Events (SRE)
Time frame: 2 years
Quality of Life as Assessed by FACT-G
Time frame: From baseline to Cycle 3 Day 1 (approximately 2 months)
Overall Tumor Response Rate
Time frame: 2 years
MET Amplification in Tumor Sample
Time frame: 2 years
Response to Cabozantinib in Bone Metastatic Disease
Time frame: 2 years
Time to SRE
Time frame: 2 years

Results and safety

Results posted to the registry on 10 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cabozantinib	37	37

Primary outcome: Number of Participants With Bone Bio-marker Response

Time frame: 8 Weeks. Count of participants. Unit: Participants

Measure	Cabozantinib n = 19
Serum Ctx	13
Urine Ntx	9
Serum Ntx	8

Population analysed: Only 19 participants were evaluable for determination of response by bone bio-markers

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cabozantinib	9 of 37 (24.3%)	37 of 37 (100%)	4 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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.

Rebecca Heist, MD principal investigator

MGH

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Lung Cancer and Solid Tumor (Not Breast or Prostate Cancers), run by Massachusetts General Hospital at 1 site 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 3 inclusion and 10 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 29 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 1 site 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 phase mean?

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 10 Jan 2018). 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 Bone Bio-marker Response (time frame: 8 Weeks). 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 NCT01588821.

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 29 Sep 2020.