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Advanced Gastric CancerPhase 1S387NCT01042782

Phase I Study of Daily RAD001 in Combination With Mitomycin C in Patients With Advanced Gastric Cancer or Cancer of the Esophagogastric Junction

A Phase 1 study testing RAD001 and MitomycinC in people with Advanced Gastric Cancer and Advanced Cancer of the Esophagogastric Junction, run by Krankenhaus Nordwest at 1 site in Germany.

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

Patients with advanced gastric cancer are treated with a combination of RAD001 (everolimus) and Mitomycin C. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RAD001 and MitomycinC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteGermany
Study dates
Jan 2008to Aug 2012
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 1 prior platin containing chemotherapy in the palliativ setting or progressive disease under adjuvant or neoadjuvant therapy within 6 months of treatment start date.
  • Histological evidence of advanced or metastatic gastric cancer or cancer of the esophageal junction.
  • At baseline CT or MRI scan must demonstrate measurable disease by RECIST criteria, i.e., the presence of at least one measurable lesion. Measurable disease lesions must be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques or > 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness).
  • At least one measurable lesion outside of the field of any prior radiation therapy (according to RECIST criteria). Prior radiotherapy to a single index lesion is not allowed.
  • Adult male or female patients (≥18 years of age).
  • Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
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  • ECOG 0 or 1
  • Life expectance >4 months
  • Adequate bone marrow function, renal function, liver function
  • Women using an acceptable form of contraception prior to receiving RAD001 or women who meet the protocol definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
  • Fully recovered from any previous surgery, prior chemotherapy or radiation therapy (at least 4 weeks since major surgery or prior myelosuppressive chemotherapy). With the exception of alopecia, patients must have resolution of all acute toxic effects of any prior surgery, radiotherapy, or chemotherapy to NCI CTC (Version 2.0) grade <=1. Patients with rapidly progressive tumors (upon the decision of the investigator) can be treated <4 weeks since last chemotherapy, if they fully recovered from all side effects.
  • Signed informed consent

Who cannot join

  • Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy. Patients with rapidly progressive tumors (upon the decision of the investigator) can be treated <4 weeks since last chemotherapy, if they fully recovered from all side effects.
  • Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
  • Patients treated with Mitomycin C
  • No neurotoxicity >= grade 2 CTC
  • No gastric or intestinal obstruction
  • Patients taking drugs known to inhibit or induce isoenzyme CYP3A
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  • Patients with any concurrent major medical condition liable to compromise the patient's participation in the study (e.g known HIV infection, uncontrolled diabetes, serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, myocardial infarction within 6 months, unstable angina, chronic or acute renal or liver disease, uncontrolled serious infections including abscess or fistulae, etc.)
  • Patients with a history of another malignancy prior to study entry, except curatively treated non-melanotic skin cancer or carcinoma in-situ cervical cancer unless in complete remission or no evidence of disease and off all therapy for that disease for a minimum of 5 years
  • No symptomatic brain metastasis.
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • Female patients who are pregnant or breast feeding
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Krankenhaus Nordwest

    Frankfurt, 60488

Other trials in Germany

About this study

Official title: Phase I Study of Daily RAD001 Administered Orally in Combination With Mitomycin C, Administered Every Three Weeks to Patients With Advanced Gastric Cancer or Cancer of the Esophagogastric Junction

Patients with advanced gastric cancer are treated with a combination of RAD001 (everolimus) and Mitomycin C.

Read the detailed description

The purpose of this monocenter, single-arm, phase I trial is to determine the maximum-tolerated-dose, dose-limiting toxicity (DLT) and preliminary efficacy and safety of RAD001 in combination with Mitomycin C in patients with advanced gastric cancer.

Being tested
RAD001 and MitomycinC
Keywords
gastric cancer, RAD001, Mitomycin C, MTD
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • RAD001 and MitomycinCDrug

    Also called RAD001 (everolimus)

    RAD001 tablets daily, 5mg, 7.5 mg or 10 mg (3 cohorts)

    Mitomycin C 5 mg/m2 i.v. every 3 weeks

Study groups in NCT01042782
Study groupRoleWhat they receive
RAD-MitCExperimentalRAD001 orally daily 5mg or 7.5mg or 10mg Mitomycin C 5mg/m2 every 3 weeks
Receives: Drug: RAD001 and MitomycinC

What is being measured

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

  1. maximum tolerated-dose (MTD) of RAD001 in combination with Mitomycin C

    Measured: every week

Secondary outcomes (4)

  1. preliminary efficacy of RAD001 in refractory gastric cancer. Efficacy is defined as complete response or partial response at 12 weeks based on RECIST-criteria

    Measured: every 6 weeks

  2. progression-free survival (PFS)

    Measured: every 6 weeks

  3. overall survival (OS)

    Measured: every three months

  4. safety and tolerability of the combination of RAD001 and Mitomycin C as assessed by frequency, severity, and duration of treatment-related adverse effects

    Measured: every week

Timeline

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

  1. First posted6 Jan 2010 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01042782
Sponsor's protocol ID
CRAD001C24126
Acronym
S387
Status last verified
Aug 2012
First submitted
5 Jan 2010
Last updated
3 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Werner D, Atmaca A, Pauligk C, Pustowka A, Jager E, Al-Batran SE. Phase I study of everolimus and mitomycin C for patients with metastatic esophagogastric adenocarcinoma. Cancer Med. 2013 Jun;2(3):325-33. doi: 10.1002/cam4.77. Epub 2013 Apr 2.

    PubMed 23930209

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RAD001 and MitomycinC in people with Advanced Gastric Cancer and Advanced Cancer of the Esophagogastric Junction, run by Krankenhaus Nordwest at 1 site 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 12 inclusion and 13 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 3 Aug 2012. 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 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

maximum tolerated-dose (MTD) of RAD001 in combination with Mitomycin C (time frame: every week). 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 NCT01042782, 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 3 Aug 2012.

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