A Clinical Study With MT-102 in Subjects With Cancer Cachexia

NCT01238107 | Completed Phase 2 DMC

• 1 other identifier: MT-102-2001
• Study Type: interventional
• Target: 87
• Locations: 3 countries
• Sites: 18

Brief Summary

A phase II clinical study to evaluate MT-102 administered over a sixteen week period in subjects with cachexia related to non-small cell lung cancer and colorectal cancer

Conditions

Cancer Cachexia

Keywords

Cachexia; Cancer

Outcome Measures

Primary Outcomes (1)

• Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer

  16 weeks

Study Arms (3)

High dose

EXPERIMENTAL

Drug: MT-102

Low dose

EXPERIMENTAL

Drug: MT-102

Placebo

PLACEBO COMPARATOR

Drug: MT-102

Interventions

MT-102 DRUG

BETA BLOCKER

High dose; Low dose; Placebo

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult patients aged between 25 to 80 years of age and with a life expectancy of greater than 3 months as judged by the treating physician.
• \. Confirmed diagnosis of one of:
• a. Non-curative stage III or stage IV Colorectal Cancer (CRC) not suitable for surgery, or b. Non-curative stage III or stage IV Non-small Cell Lung Cancer (NSCLC) not suitable for surgery;
• \. Patients who are receiving or who have already received a course of chemotherapy, with or without radiotherapy or surgery, with one of the following regimes:
• a. For non-small cell lung cancer, a platinum based regimen b. For colorectal cancer, a 5FU or Irinotecan based regimen
• \. Cachexia with ongoing weight loss that in the opinion of the investigator is due to the underlying cancer.
• \. Evidence of cachexia as judged by one of:
• a. ≥5% documented weight loss in the previous 12 months; or b. A subjective report of weight loss in the previous 12 months and a recorded body mass index (BMI) less than 20.0 kg/m2 c. Ongoing documented weight loss of at least 1kg in the week prior to day 0; or 1.25kg in the 2 weeks prior to day 0, or 1.5kg in the 3 to 6 weeks prior to day 0; provided that BMI is not more than 25.
• \. At least two of the following:
• a. Subjective report of decreased muscle strength b. Subjective report of fatigue c. Subjective report of anorexia d. Abnormal biochemistry with one or more of the following: i. CRP \> ULN (as per Central Lab normal value) ii. Anemia (\< 12 g/dl) iii. Low serum albumin (\< 3.2 g/dl) 7. Patients of childbearing potential must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives; an intrauterine device; male or female condoms; diaphragm or cervical cap with spermicide; or abstinence) prior to randomisation and must agree to continue using such precautions until the end of the 140 day safety follow up; 8. Willing and able to comply with the protocol and to complete the study period; 9. Willing to forego other forms of experimental treatment during the study; 10. Signed and dated informed consent, prior to receipt of any study medication or any study related procedures.
• \. ECOG performance status 0, 1 or 2 12. Able to complete the performance tests (SCP, SMWT, SPPB, HGS) at the screening visit and with two consecutive pre-randomisation SMWT results that differ by no more than 30% from each other 13. At least 80% compliant during the placebo run in period

You may not qualify if:

• \. Pregnancy or lactation at screen or baseline visit;
• ≥20% weight loss in the previous 3 months or a BMI of less than 16 kg/m2
• Age greater than 80 or less than 25 at baseline visit;
• Scheduled to start any new course of chemotherapy or to undergo a change in present chemotherapeutic regimen during the dose escalation phase of the study (the first three weeks after randomisation);
• Any surgical procedure within the past month or any planned surgical procedure;
• Any mechanical obstruction of the alimentary canal;
• Any history or evidence of intractable vomiting;
• A history or clinical evidence of any hyperthyroidism, cirrhosis, hepatic failure, HIV, renal failure (as determined by a serum creatinine \> 250µmol/l or \> 2.83 mg/dl at screen) or active tuberculosis (as confirmed by sputum or other microbiological methods, within the last five years);
• Any physical, medical, socioeconomic or other non-cancer related cause for simple starvation, muscle wasting or weight loss;
• Receiving enteral tube feeding or parenteral nutrition at screening or baseline visit;
• Any clinical evidence of ascites or significant oedema or significant pleural effusion at screening or baseline visit;
• Current or planned treatment with
• Any oral adrenal corticosteroids (inhaled or topical steroids and short-term use of dexamethasone around the time of chemotherapy are acceptable);
• Beta adrenergic blockers,
• Non-dihydropyridine calcium antagonists (e.g. Verapamil, diltiazem),

Sponsors & Collaborators

• Akamis Bio: lead
• Veeda Oncology: collaborator

Study Sites (18)

Charite Hospital Virchow-Klinikum Campus

Berlin, State of Berlin, d-13352, Germany

Location

Kumaran Hospital Private Ltd

Kilpauk, Chennai, 10, India

Location

Dr Kamakshi Memorial Hospital

Pallikaranai, Chennai, 600100, India

Location

Vedanta Institute of Medical Science

Ahmedabad, Gujarat, 380009, India

Location

Shree Krishna Hopsital

Anand, Gujarat, 388325, India

Location

Kailash Cancer Hospital & Research Centre

Goraj, Gujarat, 391760, India

Location

TATA Memorial Hopsital

Mumbai, Maharashtra, 400012, India

Location

Curie Manavta Cancer Centre

Nashik, Maharashtra, 422004, India

Location

Shatabdi Super Speciality Hospital

Nashik, Maharashtra, 422005, India

Location

Noble Hopsital

Pune, Pune, 411013, India

Location

Hospital Sultahan Bahiyah

Alor Star, Kedha, 05460, Malaysia

Location

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Hospital Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Universiti Malaya Medical

Jalan Baharu, Kuala Lumpur, 50603, Malaysia

Location

Tuanku Ja'afar Hospital

Seremban, Negeri Sembilan, 70300, Malaysia

Location

International Islamic University Malaysia

Kuantan, Pahang, 25200, Malaysia

Location

Penang General Hopsital

Pulau Pinang, Pulau Pinang, 10990, Malaysia

Location

Hospital Umum Sarawak

Kuching, Sarawak, 93586, Malaysia

Location

MeSH Terms

Conditions

Cachexia; Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Kumar n Pradhash, MD

  TATA MEMORIAL HOSPITAL , MUMBAI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: April 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

IN (9); DE (1); MY (8)